MicroVention TERUMO Scepter C Occlusion Balloon Catheter Instructions

MicroVention TERUMO Scepter C Occlusion Balloon Catheter

Specifications

• Product Name : Scepter CTM / Scepter XCTM Occlusion Balloon Catheter
• Contents : One Occlusion Balloon Catheter, One Introducer Sheath, One Shaping Mandrel, One Compliance Card
• Intended Use : Temporary occlusion in peripheral and neuro vasculature, infusion of diagnostic and therapeutic agents
• Contraindications: Not for embolectomy or angioplasty, not for coronary vessels, not for pediatric or neonatal use
• Caution: Rx Only, dispose according to hospital policies

Product Usage Instructions

Indications for Use / Intended Purpose

The Scepter C and Scepter XC Occlusion Balloon Catheters are designed for:

• Temporary occlusion in peripheral and neuro vasculature for stopping or controlling blood flow.
• Balloon-assisted embolization of intracranial aneurysms.
• Infusion of diagnostic and therapeutic agents in peripheral and neuro vasculature.

Warnings

• Verify vessel size under fluoroscopy before use.
• Avoid exceeding the maximum inflation volume to prevent balloon rupture.
• Use only approved embolization materials compatible with the catheter.
• Avoid air entering the balloon during preparation.
• Avoid using high-pressure devices on the inflation port to prevent rupture.

Preparation and Usage Tips

1. Ensure proper vessel size matches before insertion.
2. Do not inflate the balloon with air or any other gas.
3. Avoid introducing air into the system during preparation.
4. Inject fluid slowly during air purging to prevent balloon rupture.
5. Avoid over-tightening the RHV around the catheter.

Cleaning and Disposal

After use, follow hospital protocols for disposal. Do not reuse the catheter.

FAQ

• Can the Scepter CTM / Scepter XCTM Occlusion Balloon Catheter be used in pediatric patients?
  • No, the catheter is not intended for pediatric or neonatal use.
• What should I do if resistance is felt while advancing the catheter or guidewire?
  • If resistance is encountered, stop advancement and assess the source of resistance using fluoroscopy.

Instructions for Use

DEVICE DESCRIPTION

The Scepter C and Scepter XC Occlusion Balloon Catheters are dual-lumen catheters with an external hydrophilic coating. The guidewire lumen is provided for guidewire introduction and delivery of agents. The inflation lumen is used exclusively for the inflation and deflation of the balloon. The guidewire lumen of the balloon catheters are compatible with 0.014 inch or smaller guidewires and the balloon can be inflated and deflated independently with or without the presence of a guidewire. The balloon catheters are available in different sizes and lengths and incorporate radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position. The balloon incorporates a distal air-purge hole to purge air from the inflation lumen prior to use.

The Scepter C and Scepter XC Occlusion Balloon Catheters are intended for single use only. Do not sterilize or reuse the balloon catheters. After use, dispose of the catheter in accordance with hospital, administrative and/or local government policy. Do not use the balloon catheters if the sterile package is breached or damaged.

CONTENTS

One Occlusion Balloon Catheter
One Introducer Sheath
One Shaping Mandrel
One Compliance Card

INDICATIONS FOR USE / INTENDED PURPOSE

The Scepter C and Scepter XC Occlusion Balloon Catheters are intended: For use in the peripheral and neuro vasculature where temporary occlusion is desired. The balloon catheters provide temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheters also offer balloon-assisted embolization of intracranial aneurysms. For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents such as embolization materials.

For neurovascular use for the infusion of diagnostic agents such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.

CONTRAINDICATIONS

Not intended for embolectomy or angioplasty procedures
Not intended for use in coronary vessels
Not intended for pediatric or neonatal use

CAUTION

Rx Only : Federal (USA) law restricts this device to sale by or on the order of a physician. Do not use if the pouch is opened or damaged.

This device is intended for single use only. Do not resterilize or reuse. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose in accordance with hospital, administrative and/or local government policy.

WARNINGS

Verify the size of the vessel under fluoroscopy. Ensure that the balloon catheter is appropriate for the size of the vessel.

Do not exceed the maximum recommended inflation volume as balloon rupture may occur. The balloon catheter has been tested for compatibility or use with Onyx™ Liquid Embolic System and DMSO. For all other liquid embolics, refer to their Instructions For Use.
The balloon catheter is provided sterile and non-pyrogenic. Do not use if the packaging is breached or damaged.

Viscosity and concentration of contrast will affect balloon inflation and deflation times.

During preparation, do not deflate the balloon unless the distal tip is submerged in saline or contrast to prevent air from entering the balloon.

Do not attach any high-pressure devices to the balloon inflation port as this may rupture the balloon.

Do not inflate the balloon with air or any other gas while in the body.

Improper preparation may introduce air into the system. The presence of air may inhibit proper fluoroscopic visualization.

Excessive pressure higher than 700 PSI (4826kPa, 47.6atm) may cause leakage or rupture of the balloon catheter guidewire lumen.
When air-purging the balloon catheter, inject fluid slowly otherwise balloon rupture may occur.

If back-loading the balloon catheter over a guidewire, ensure distal tip of the balloon catheter is not damaged.

Do not over-tighten the RHV around the balloon catheter. Over-tightening could damage the catheter shaft and delay balloon inflation and deflation.

Do not advance the balloon catheter or guidewire against resistance. If resistance is felt, assess the source of resistance using fluoroscopic means.

Always inflate and deflate the balloon while visualizing under fluoroscopy to ensure patient safety.

The shaping mandrel is not intended for use inside the body. Ensure the shaping mandrel is removed from the balloon catheter prior to introduction into the RHV or other accessories.

NBCA and solutions containing ethyl esters of iodized fatty acids of poppy seed oil are not compatible with the balloon.

Users and/or patients should report any serious incidents to the manufacturer and the Competent Authority of the Member State or Local Health Authority in which the user and/or patient is established.

PRECAUTIONS

Immediately prior to use visually inspect all the sterile barrier systems, that are labeled as sterile. Do not use if breaches in sterile barrier system integrity are evident such as a damaged pouch. After balloon preparation for use and prior to use, re-inflate to nominal volume and inspect for any irregularities or damage. Do not use if any inconsistencies are observed. Verify balloon catheter compatibility when using other ancillary devices commonly used in intravascular procedures. Physicians must be familiar with percutaneous, and intravascular techniques and possible complications associated with the procedure.

The balloon catheter has a lubricious surface and should be hydrated for at least 30 seconds prior to use. Once the balloon catheter is hydrated, do not allow it to dry. Protect the balloon when tip steam shaping or purge hole sealing of the balloon catheter as it may affect the integrity of the balloon material.

Exercise care in handling the balloon catheter to reduce the chance of accidental damage. With the exception of dimethyl sulfoxide (DMSO), use of other organic solvents may damage the balloon catheter and/or coating on the surface.

DMSO-based embolization materials should only be used in accordance with their neurovascular approved intended use.

Verify that the diameter of any guidewire or accessory device used is compatible with the inner diameter of the balloon catheter prior to use.

Take precautions when manipulating the balloon catheter in tortuous vasculature to avoid damage. Avoid advancement or withdrawal against resistance until the cause of resistance is determined. The presence of calcifications, irregularities or existing devices may damage the balloon catheter and potentially affect its insertion or removal.

Always verify proper balloon vessel occlusion prior to and during embolic material delivery. Sealing the purge hole prior to embolic material delivery may provide assistance during use. Excessive torque applied to the syringe might result in damage to the Scepter hub assembly. Exercise necessary precautions to limit X-radiation doses to patients and operators by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.

Continuing negative aspiration after the balloon is fully deflated will result in blood entering the balloon and will reduce fluoroscopic visibility.

POTENTIAL COMPLICATIONS

Potential complications include but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at
the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.

Exposure to angiographic and fluoroscopic X-radiation presents potential risks of alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia that increase in probability as procedure time and number of procedures increase.

COMPATIBILITY

Scepter C and Scepter XC balloon catheters are compatible with .014” (0.36mm) or smaller guidewires
Note : Guidewire not required for inflation of balloon Choose appropriate guiding catheter with a minimum inner diameter larger than or equal to 0.053” (1.35mm)

Note: The maximum outer diameter of the balloon catheter is 0.038” (0.97mm) Scepter C and Scepter XC balloon catheters are compatible for use with dimethyl sulfoxide (DMSO). Scepter C and Scepter XC balloon catheters have been verified to be compatible for use with diagnostic agents (such as contrast media), and liquid embolic agents (i.e. Onyx™ Liquid Embolic System). For all other liquid embolics and therapeutic agents, refer to their Instructions For Use.

HYDRATION FLUSH

1. Choose a balloon catheter that is appropriate for the size of the vessel.

2. Before removing the balloon catheter from the dispenser tube, gently pull the hub out from the dispenser tube in order to loosen the strain relief from the dispenser tube, fully hydrate the hydrophilic segment of the device by flushing heparinized saline through the dispenser tube using a syringe attached to the flush port. Allow 30 seconds of hydration time.
   Table 1: Approximate Balloon Deflation Time

Contrast Name

| Viscosity @

37˚C

(cps)

|

Contrast: Saline

| Scepter C (seconds)| Scepter XC (seconds)
4x10mm| 4x15mm| 4x20mm| 4x11mm
Omnipaque 300| 6.3| 50:50| ≤ 15| ≤ 18| ≤ 20| ≤ 14
Table 2:
Approximate Prime Volume of the Entire Inflation

Lumen

| Approximate Prime Volume of the Entire

Guidewire Lumen

Volume of Inflation Lumen + Inflation Hub| Volume of Guidewire Lumen + Guidewire Hub
0.45cc| 0.44cc

BALLOON PREPARATION

1. Use a syringe with heparinized saline to flush the guidewire lumen. Remove the syringe. Attach a rotating hemostatic valve (RHV) to the guidewire lumen. Carefully introduce a hydrated guidewire into the guidewire lumen of the balloon catheter.
   WARNING : Excessive pressure higher than 700PSI (4826kPa, 47.6atm) may cause leakage or rupture of the balloon catheter.

2. Remove the balloon catheter by pulling it from the dispenser tube. If resistance is observed, repeat the flushing procedure in preparation for use until the balloon catheter is well-hydrated and can be easily removed from the dispenser tube. Inspect the balloon catheter thoroughly to ensure it is not damaged. Do not allow the balloon catheter to dry prior to introduction into the guiding catheter. Do not reinsert a hydrated balloon catheter into its packaging.

3. Prepare a contrast/saline solution using Table 1 as a guide.

   • WARNING : Viscosity and concentration of contrast will affect balloon inflation and deflation times.

4. Fill a 10cc syringe (with or without a stopcock) with contrast/saline solution and carefully attach to the inflation port without injecting contrast into the hub. Ensure there are no bubble(s) in a syringe (and stopcock) prior to attaching

5. Hold the balloon proximal to the inflation plug and point the balloon upright with one hand.

6. Hold the attached syringe with the other hand and apply pressure on the syringe plunger using a thumb.

7. If the balloon is initially inflated with air then maintain constant syringe pressure.
   WARNING : Do not fully inflate a balloon with air. Maintain balloon inflation below the distal balloon marker band.

8. Maintain pressure and DO NOT TILT the balloon until the contrast reaches the distal purge hole and the contrast has completely filled the balloon.

9. Once the balloon has been fully inflated with contrast, inspect the balloon for any damages and bubbles. If air bubbles persist, use the aspiration technique outlined in Step A otherwise place tip in saline bowl, and deflate the balloon.

10. Remove the 10cc syringe and attach a stopcock (if it has not been attached before) to a 1cc syringe-filled
    with contrast/saline solution.

11. Prime the 1cc syringe and stopcock with contrast/saline solution, attach to the hub of the primed inflation port and proceed to steps B, C or D.

ALTERNATE BALLOON PREPARATION

1. Remove the balloon catheter by pulling it from the dispenser tube. If resistance is observed, repeat the flushing procedure until the balloon catheter is well hydrated and can be easily removed from the dispenser tube. Inspect the balloon catheter thoroughly to ensure it is not damaged. Do not allow balloon catheter to dry prior to introduction into the guiding catheter. Do not reinsert a hydrated balloon catheter into its packaging.

2. Hydrate the guidewire lumen of the balloon catheter with saline. See table 2 for approximate prime volume. Carefully introduce a hydrated guidewire into the guidewire lumen of the balloon catheter.
   WARNING: Excessive pressure higher than 700PSI (4826kPa, 47.6atm) may cause leakage or rupture of the balloon catheter.
   WARNING: If back-loading the balloon catheter over a guidewire, ensure distal tip of the balloon catheter is not damaged.

3. Prepare a contrast/saline solution using Table 1 as a guide.
   WARNING: Viscosity and concentration of contrast will affect balloon inflation and deflation times.

4. Fill the hub of the inflation port with contrast/saline solution using an introducer needle attached to a 1cc syringe.

5. Remove the introducer needle and attach a stopcock to a 1cc syringe filled with contrast/saline solution.

6. Prime the stopcock with contrast/saline solution and attach it to the hub of the primed inflation port.

7. Place the balloon catheter into a large bowl of saline for continued hydration. Note: keep the catheter in a horizontal position while submerged in the saline solution. With the distal tip of the balloon catheter submerged in saline, slowly inject contrast/saline solution through the balloon inflation port and allow all the air to escape from the distal air-purge hole. During this air-purging process, caution should be taken to inject slowly to prevent the balloon from inflating with the air. If the balloon is inflated before the contrast/saline solution reaches the balloon, stop air-purging the balloon to allow the balloon to deflate. Slowly inject contrast/saline solution again allowing the remaining air to escape through the distal air-purge hole. Reference table 2 for the total prime volume of the inflation hub and the inflation lumen. An additional solution will be required to inflate the balloon.
   WARNING: During air-purging of a balloon catheter, inject fluid slowly otherwise balloon rupture may occur.

8. After air-purging the balloon catheter inflation lumen, continue to slowly inflate the balloon with the contrast/saline solution. The balloon will inflate from proximal to distal during the initial inflation. When the balloon catheter is completely inflated, check for the presence of additional air bubbles. If any air bubbles are present, submerge the tip of the balloon catheter in saline and deflate completely, then slowly inflate with the balloon held upright to allow any remaining air to escape from the distal air-purge hole. If bubbles persist, use the aspiration technique outlined in Step A, otherwise place tip in saline bowl, deflate the balloon  and proceed to step B, C or D
   NOTE: When air-purging, keep the balloon catheter hydrated during the preparation procedure to prevent the coating from drying.
   WARNING: When air-purging of the balloon catheter, inject fluid slowly otherwise balloon rupture may occur.
   WARNING: Do not deflate the balloon unless the distal tip is submerged in saline or contrast to prevent air from getting back into the balloon.

   • WARNING: Keep the balloon catheter hydrated during the preparation procedure by periodically submerging in
     saline as required

A. ASPIRATION TECHNIQUE:

1. Attach a 3-way stopcock to a 20cc syringe filled with 3cc of contrast/saline solution.

2. Connect the 20cc syringe/stopcock to the balloon catheter inflation port.

3. With the syringe pointed down and the stopcock in open position, pull the vacuum on the syringe.

4. Remove the balloon from the saline bowl and place the distal tip of the balloon in air.

5. Hold the vacuum until the inflation port is clear of contrast/saline mix.

6. Close the stopcock to the inflation lumen, point the syringe up and purge air.

7. Open the stopcock to the inflation lumen, point the syringe down and pull vacuum again.

8. Slowly remove the vacuum by lowering plunger and let the system equalize.

9. Replace 20cc syringe with 1cc syringe filled with contrast/saline solution.
   WARNING: Keep the balloon catheter hydrated during the preparation procedure by periodically
   submerging in saline as required.

10. Advance guidewire distally or insert a straight shaping mandrel to ensure the balloon is straight.

11. Hold tip upright to allow air to escape and slowly infuse contrast/saline until the balloon is inflated to
    the nominal diameter.

12. If no air bubbles are visible inside the balloon, place tip in a saline bowl, deflate the balloon and then
    proceed to Step B, C or D. If air bubbles persist, repeat step A or discard the balloon catheter.

B. TIP SHAPING TECHNIQUE:

NOTE: Tip shaping must be performed AFTER the balloon catheter has been purged and has been properly prepared per instructions.

1. Bend the shaping mandrel for the desired shape.

2. With the balloon deflated, carefully insert the shaping mandrel into the distal end of the guidewire lumen.

3. Hold the bottom of the compliance card with the “balloon side” facing the user.

4. Hold the balloon proximal to the inflation port with the hand resting on the center of the compliance card for stability.

5. Place the distal tip marker band with the bend at the bottom and inside of the steam groove. (see Figure 2)

   • NOTE: Exposing more than 3mm of the distal tip to steam will result in balloon damage.
     PRECAUTION: Discretion should be taken not to contaminate the balloon catheter during steaming

6. Hold the distal tip marker band in laminar steam flow close to the source of steam for approximately 20 seconds.
   NOTE: Ensure that the compliance card is protecting the balloon from the steam heat source or the balloon may be damaged.

7. Remove the catheter tip and compliance card from steam.

8. Gently remove the balloon catheter tip from compliance card and quench in heparinized saline.

9. Gently remove tip-shaping mandrel.
   WARNING: The shaping mandrel is not intended for use inside the body.

10. Proceed to step D.

C. AIR PURGE HOLE SEALING TECHNIQUE:

NOTE: Air-purge hole sealing must be performed AFTER the balloon catheter has been purged and has been properly prepared per instructions.

1. With the balloon deflated, carefully insert the shaping mandrel into a distal end of the guidewire lumen.

2. Hold the bottom of the compliance card with the “balloon side” facing the user.

3. Hold the balloon proximal to the inflation port with the hand resting on the center of the compliance card for stability.

4. Place the distal tip marker band at the bottom and inside of the steam groove. (see Figure 2)
   NOTE: Exposing more than 3mm will result in balloon damage.
   PRECAUTION: Discretion should be taken not to contaminate the balloon catheter during steaming.

5. Hold the distal tip marker band in laminar steam flow close to the source of steam for approximately 20 seconds
   NOTE : Ensure that the compliance card is protecting the balloon from steam heat source or the balloon may be damaged.

6. Remove the catheter tip and compliance card from the steam source.

7. Gently remove the balloon catheter tip from compliance card and quench in heparinized saline. Gently remove tip-shaping mandrel. WARNING: Shaping mandrel is not intended for use inside the body.
   NOTE : Improper exposure to steam may result in a partially sealed air- purge hole. Inspection of inflated balloon catheter under fluoroscopy must be performed frequently to ensure desired occlusion at all times.

8. Proceed to step D.

D. BALLOON FINAL INSPECTION

1. Re-inflate the balloon to nominal volume to inspect the balloon catheter prior to use for any irregularities or damage. Do not use if any inconsistencies are observed.
2. If air purge hole sealing was performed, inspect the balloon catheter distal tip for any contrast leakage from air purge hole. If contrast leakage is observed then repeat the air-purge hole sealing technique outlined in step C.

3. Deflate once more while distal tip is submerged in saline and let the pressure within the catheter equalize. With the catheter and balloon completely primed, the balloon catheter is ready for use.
   WARNING: Do not attach any high-pressure devices to the balloon inflation port as this may rupture the balloon.
   WARNING: Do not inflate the balloon with air or any other gas while in the body.
   WARNING: Improper preparation may introduce air into the system. This may inhibit proper fluoroscopic visualization. Table 3: Balloon Inflation Compliance

   Inflation Volume* (cc)| Scepter C

Dia., (mm)

| Scepter XC

Dia., (mm)

4×10| 4×15| 4×20| 4×11
0.02| 1.9| 1.8| 1.8| 1.8
0.04| 2.6| 2.4| 2.4| 2.6
0.06| 3.0| 2.9| 2.8| 3.2
0.08| 3.2| 3.2| 3.1| 3.6
0.10| 3.5| 3.4| 3.3| 3.9
0.12| 3.6| 3.5| 3.4| 4.2
0.14| 3.8| 3.7| 3.6| 4.5
0.16| 4.0| 3.8| 3.7| 4.7
0.18| 4.1| 4.0| 3.8| 4.9
0.20| 4.2| 4.1| 3.9| 5.0
0.22| 4.4| 4.2| 4.0| 5.2
0.24| 4.5| 4.3| 4.1| 5.3
0.26| 4.6| 4.5| 4.2| 5.5
0.28| 4.7| 4.6| 4.3| 5.6
0.30| 4.8| 4.7| 4.4| 5.7
0.32| 4.9| 4.8| 4.4| 5.9
0.34| | 4.9| 4.5|
0.36| | 4.9| 4.6|
0.38| | 5.0| 4.6|
0.40| | | 4.7|
0.42| | | 4.8|
0.44| | | 4.9|
0.46**| | | 4.9|

Table 4

| Approximate Nominal Flow Rates at 100 and 300 psi Infusion Pressure
---|---
Saline| 50/50% Contrast (300mgI/ml)| 100% Contrast (300mgI/ml)| 100% Contrast (350mgI/ml)

Scepter C & XC

| 100 psi| 300 psi| 100 psi| 300 psi| 100 psi| 300 psi| 100 psi| 300 psi
0.57

cc/sec

| 1.50

cc/sec

| 0.49

cc/sec

| 0.71

cc/sec

| 0.33

cc/sec

| 0.62

cc/sec

| 0.40

cc/sec

| 0.40

cc/sec

DIRECTIONS FOR USE (Refer to the diagram for reference)

1. Attach a rotating hemostatic valve (RHV) (if it has not been attached before) to the guidewire lumen of the balloon catheter. Set up a continuous saline flush line and connect it to the sidearm of the RHV.

2. Choose an appropriate guiding or diagnostic catheter. Attach a RHV to the proximal hub of the guiding or diagnostic catheter. To prevent backflow of blood into the lumen of the catheter, connect the continuous saline flush line to the sidearm of the RHV.

3. Open the RHV on the hub of the guiding or diagnostic catheter and introduce the balloon catheter/guidewire into the guiding catheter using the introducer sheath. Carefully advance the balloon catheter/guidewire to the guiding catheter distal tip. After the balloon catheter/guidewire reaches the tip of the guiding catheter, remove the introducer from the balloon catheter shaft by retracting the introducer from the RHV and peeling off the introducer. Advance the balloon catheter through the RHV.

4. Advance the balloon catheter and guidewire to the desired location in the vasculature using fluoroscopic visualization. Carefully tighten the valve of the RHV around the balloon catheter to prevent leakage from the RHV. The RHV should still allow for balloon catheter advancement after tightening. WARNING: Do not over-tighten the RHV around the balloon catheter. Over-tightening could damage the catheter shaft and delay balloon inflation and deflation.
   WARNING : Do not advance the balloon catheter or guidewire against resistance. If resistance is felt, assess the source of resistance using fluoroscopic means.

5. Attach a 1-way stopcock to a 1cc syringe filled with appropriate contrast solution. Prime the 1-way stopcock so that no air is present. Slowly inflate the balloon to the recommended volume to achieve the desired diameter as described in Table 3.
   WARNING: Do not exceed the maximum recommended inflation volume as balloon rupture may occur.
   WARNING: Always inflate and deflate the balloon while visualizing under fluoroscopy to ensure patient safety.

6. After inflation, lock the stopcock if desired.

7. If desired, remove the guidewire from the balloon catheter and prepare per the respective diagnostic or therapeutic agent IFU(s) for delivery through the guidewire lumen.
   WARNING: Excessive pressure higher than 700PSI (4826kPa, 47.6atm) may cause leakage or rupture of the guidewire lumen.

8. When deflating the balloon, use fluoroscopy to ensure complete deflation prior to removal. See Table 1 for
   respective deflation times. After the procedure is complete, slowly remove the balloon catheter and guidewire.

STORAGE

Keep dry and away from sunlight. See the product label for the device’s shelf life. Do not use the device beyond the labeled shelf life.

MATERIALS

The balloon catheter does not contain latex or PVC materials.

SUMMARY OF SAFETY AND CLINICAL PERFORMANCE

The Summary of Safety and Clinical Performance (SSCP) for the device will be accessible in the European database on medical devices after the launch of the European Database on Medical Devices (Eudamed) (Eudamed: https://ec.europa.eu/tools/eudamed).
The SSCP will be linked to the Basic UDI-DI in the Eudamed public website.

SYMBOLS

WARRANTY

MicroVention, Inc. warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness. Handling, storage, cleaning and sterilization of the device as well as factors relating to the patient, diagnosis, treatment, surgical procedure and other matters beyond MicroVention’s control directly affect the device and the results obtained from its use. MicroVention’s obligation under this warranty is limited to the repair or replacement of this device and MicroVention shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device. MicroVention neither assumes nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. MicroVention assumes no liability with respect to devices reused, reprocessed or resterilized and makes no warranties, expressed or implied, including, but not limited to, merchantability or fitness for intended use, with respect to such device.

Prices, specifications and model availability are subject to change without notice. MicroVention™ is a registered trademark of MicroVention, Inc. in the United States and other jurisdictions.

Third-party trademarks remain the property of their respective owners. Use of them does not imply any affiliation or endorsement of the trademarks.
© Copyright 2024 MicroVention, Inc. All rights reserved. eIFU website: www.microvention/eIFU-MicroVention.com

Manufacturer:

MicroVention, Inc.
35 Enterprise
Aliso Viejo, CA 92656 USA
Tel: 714-247-8000
www.microvention.com

Authorized European Representative and Importer:

MicroVention Europe SARL 30 bis, rue du Vieil Abreuvoir 78100 Saint-Germain- en-Laye France
Tel: +33 (0)1 39 21 77 46
Fax: +33 (0)1 39 21 16 01

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