philips P017521 LLD Lead locking device Instruction Manual

philips P017521 LLD Lead locking device

Description

LLD and Clearing Stylet

The Spectranetics Lead Locking Device or LLD is comprised of two-wire loop handles and a core mandrel that has a stainless steel mesh fixation mechanism. This mesh is attached at the distal end within a radiopaque marker for visibility under fluoroscopy. The proximal end of the mesh is attached to a proximal connector which is used to deploy and lock the device into the pacing or defibrillator lead. The proximal connector is seated on a crimped section of the core mandrel until it is deployed. The connector slides distally from the crimped section and deploys the mesh inside the lead.

• Non-Deployed LLD, “Insertion” Configuration
• Deployed LLD, “Locked” Configuration

The LLD is packaged with a clearing stylet. The clearing stylet consists of a stainless steel mandrel attached to a proximal handle. Table 1 identifies LLD device ranges and Clearing Stylet sizes.

Device Range

Model Number| Device Number| L ead Internal Diameter

R ange (in / mm)

| Clearing Stylet Number

D iameter (in/mm)

---|---|---|---
518 – 018

518 – 021

| LLD #| 0.013 – 0.016 / 0.33 – 0.4| (0.012 / 0.30)
518 – 019

518 – 022

| LLD #2| 0.017 – 0.026 / 0.43 – 0.66| 2  (0.015 / 0.38)
518 – 020

518 – 023

| LLD #3| 0.027 – 0.032 / 0.69 – 0.8| 2  (0.015 / 0.38)
518 – 039| LLD E| 0.015 – 0.023/ 0.38 – 0.58| (0.012 / 0.30)
518 – 062

518 – 067

| LLD EZ| 0.015 – 0.023 / 0.38 – 0.58| (0.012 / 0.30)

Lead Cutter

The Spectranetics Lead Cutter is used to gain access to the inner lumen of a pacing/ defibrillator lead by cutting through the insulation and coils cleanly. The lead cutter is constructed with stainless steel.

Accessory Kit
The Spectranetics Accessory Kit contains a Coil Expander and two Pin Gauges. Coil Expander: Used to restore the proximal end of lead coils to a circular profile. The Coil Expander contains a stainless steel tapered pin inserted into a polycarbonate handle. The Coil Expander opens the proximal end of the lead coil. This process promotes an accurate measurement by the Pin Gauges. Pin Gauges: The Pin Gauges are used to determine which Lead Locking Device (LLD) is appropriate for the pacing/defibrillator lead to be extracted. The Pin Gauges are made with stainless steel pins inserted
into a polycarbonate handle. Each Pin Gauge contains two pins. One Pin Gauge has the #1 and E/EZ pins, the second Pin Gauge has the #2 and #3 pins.

LLD Size Selection

The appropriate LLD is selected by using the Spectranetics Pin Gauges as described on Table 2 below.

Selection Chart

For leads with internal diameter greater than 0.023” / 0.58mm, select LLD #2.
The LLD may be used in conjunction with the Spectranetics Laser Sheath Kit or other necessary extraction devices. Closely follow the Instructions for Use for any device used during the extraction procedure.
NOTE : The LLD is a single-use disposable device and is intended to be used in one lead.
NOTE : Any device used over the lead to be extracted must have an ID greater than the target lead maximum diameter.

Indications for Use

The Spectranetics Lead Locking Devices, LLD, are intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using asuperior venous approach.

Contraindications

Use of the LLD is contraindicated:

• When emergency thoracotomy with cardiopulmonary bypass cannot be performed immediately in the event of a life threatening complication;
• When fluoroscopy is not available;
• In patients in whom superior venous approach cannot be used;
• When the proximal end of the pacing lead is not accessible to the operator;
• When the LLD will not fit into the inner lumen of the device to be extracted.

Warnings

Do not attempt to use the LLD without the availability of the Spectranetics Laser Sheath or other necessary lead removal tools. The LLD should be used only by physicians who are experienced in lead removal techniques. Do not insert more than one LLD into a lead lumen at a time. Lead removal devices should be used only at institutions with emergency cardiac surgical capabilities. Weigh the relative risks and benefits of intravascular lead removal procedures particularly when:

• The item to be removed is of a dangerous shape or configuration.
• The likelihood of lead disintegration resulting in fragment embolism is high.
• Vegetations are attached to the lead body.

When using the LLD:

• Do not abandon a lead in a patient with a LLD still inside the lead. Severe vessel or endocardial wall damage may result from the sti need lead or from fracture or migration of the abandoned device.
• Do not apply weighted traction to an inserted LLD as myocardial avulsion, hypotension, or venous wall tearing may result.
• Excessive applied traction forces may impact the LLD’s ability to disengage from a lead. Be aware that a lead that has a J-shape retention wire that occupies its inner lumen (rather than being outside the coil) may not be compatible with the LLD. Insertion of the LLD into such a lead may result in protrusion and possible migration of the J-shape retention wire. Do not use a Metal Reinforced Flexible Dilator Sheath to apply myocardial countertraction.

When the LLD is in the body, it should be manipulated only under fluoroscopic observation.
Maintain appropriate traction on the LLD and device being extracted during the advancement of the Spectranetics Laser Sheath. When marked calcification that moves with the device to be extracted is seen on fluoroscopy, particularly in the atrium, the availability of immediate surgical assistance is paramount if a problem presents itself as a result of the extraction procedure. Also, thoracotomy removal of the device (s) should be considered.

Precautions

Thoroughly review appropriate package inserts for the Spectranetics Laser Sheath (SLS) before attempting to use the SLS with the LLD.
For single use only. Do not resterilize and/or reuse. The LLD is intended to be used in one lead.
DO NOT resterilize or reuse this device, as these actions can compromise device performance or increase the risk of cross-contamination due to inappropriate reprocessing. Reuse of this single-use device could lead to serious patient injury or death and voids manufacturer warranties.
Do not use the LLD:

• If the tamper-evident seal is broken;
• If the LLD has been damaged.

When the LLD is in the body, it should be manipulated only under fluoroscopic observation.
Prior to the procedure, consider the size of the lead to be extracted in relation to the size of the Lead Extraction Devices and LLD. Any device used over the lead to be extracted must have an ID greater than the target lead maximum outer diameter.
Due to rapidly evolving lead technology, this device may not be suitable for the removal of all types of leads. If there are questions or concerns regarding the compatibility of this device with particular leads, contact the lead manufacturer. If selectively removing leads with the intent to leave one or more chronically implanted leads intact, these non-targeted leads must be subsequently tested to ensure that they were not damaged or dislodged during the extraction procedure.

Adverse Events

Commonly observed adverse events during lead removal procedures have included:

• Hemopericardium Tamponade
• Hemothorax
• Thrombosis
• Tricuspid Regurgitation
• Infection
• Death

The following adverse events or conditions may also occur during lead removal (listed in alphabeticalorder):

• Bacteremia
• Low cardiac output
• Migration of lead fragments
• Migration of vegetation
• Myocardial avulsion
• Premature ventricular contractions
• Pulmonary embolism
• Stroke
• Venous avulsion
• Ventricular tachycardia

Additional information may be found in the articles referenced in the bibliography.

Individualization of Treatment

Weigh the relative risks and benefits of intravascular lead removal procedures in cases where:

• The lead to be removed has a sharp bend or evidence of fracture;
• The lead shows evidence of insulation disintegration raising the concern of pulmonary embolism;
• Vegetations are attached to the lead body.

When an outer sheath is left in place following lead removal, it may then be used as a conduit to facilitate the implantation of a new lead.The sheath tip should be either (a) fully into the atrium, or (b) retracted into the brachiocephalic vein. Placing the outer sheath tip at the SVC-atrial junction risks damage to this delicate area during subsequent procedures, such as moving the outer sheath or implanting a new lead and is thus not recommended. It is vital that appropriate traction be maintained on the lead being extracted during all extraction attempts. If appropriate levels of traction cannot be maintained to set the counter-pressures that distort the lead body, changing to an alternative extraction procedure should be considered. When marked calcification that moves with the lead to be extracted is seen on fluoroscopy, particularly in the atrium, the availability of immediate surgical assistance is paramount if a problem presents itself because of the extraction procedure. Also, an indication for thoracotomy removal of the lead(s) should be considered.

How Supplied

Sterilization
For single use only. Do not re-sterilize and/or reuse.
The LLD, Accessory Kit, and Lead Cutter have been sterilized using Ethylene Oxide and are supplied sterile and Non-Pyrogenic. Sterilityis guaranteed only if the package is unopened and undamaged.

Transportation and Storage

Keep dry. Store in a cool dry place. Protect from direct sunlight and high temperature (greater than 60°C or 140°F).

Inspection Prior to Use

Before use, visually inspect the sterile package to ensure that seals have not been broken. Allequipment to be used for the procedure, including the LLD, should be examined carefully for defects. Examine the LLD for bends, kinks or other damage. Do not use if it is damaged or unintentionally opened..

Compatibility

See “Description” section.

Directions for Use

NOTE: “LLD” refers to all LLD devices (#1, #2, #3, E, and EZ).
WARNING: Do not abandon a lead in a patient with a LLD still in place. Severe vessel or endocardial wall damage may result from the still ened lead or from fracture or migration of the abandoned LLD body.
WARNING: Be aware that a lead that has a J-shape retention wire that occupies its inner lumen (rather than being outside the coil) may not be compatible with the LLD. Insertion of the LLD into such a lead may result in protrusion and possible migration of the J-shape retention wire.
WARNING : Excessive applied traction forces may impact the LLD’s ability to disengage from a lead.
WARNING : Do not apply weighted traction to an inserted LLD as myocardial avulsion, hypotension, or venous wall tearing may result.

Clinical Technique

Thoroughly review appropriate package inserts for Spectranetics Laser Sheaths or other necessary lead extraction tools before attempting to use the LLD.

Procedure Set Up

LLD Preparations:
Using sterile technique, open the sterile package.

Patient preparations:Patient preparations:

• Obtain a thorough patient history, including patient blood type. Appropriate blood products should be readily available.
• Ascertain the manufacturer, model number and implant date of the lead to be removed. Perform radiographic / echo-cardiographic evaluation of lead condition, type and position.
• Use a procedure room that has fluoroscopy, pacing equipment, defibrillator, and thoracotomy and pericardiocentesis trays.
• Prep and drape the patient’s chest for possible thoracotomy; prep and drape the patient’s groin for a possible femoral approach extraction procedure. If a femoral approach becomes necessary, the LLD is contraindicated.
• Establish back-up pacing as needed.

Procedure

1.  After the proximal end of the lead has been exposed, sutures and tie-down materials removed, and the proximal fittings (if present) cut, using the Spectranetics Lead Cutter or another suitable instrument, expose the inner coil of the lead.
   NOTE : For a unipolar lead, if the lead is long enough, use a scalpel to circumscribe the insulation two centimeters from the cut proximal end of the lead (do this carefully to avoid deforming the coil), then pull the insulation off to expose the inner coil.
   For a bipolar lead with coaxial coils, remove the outer coil and inner insulation to expose the inner coil and prevent it from being pushed deeply into the outer coil.
   Once the inner lumen of the lead is exposed, insert the Spectranetics Coil Expander to ensure that there is no obstruction to insertion of the Spectranetics Pin Gauges used to size the appropriate LLD.
   NOTE : Examine the lumen to be sure the interior coil is not flattened and there are no burrs that would inhibit passage of the Spectranetics Pin Gauges or the LLD into the lumen.

2. Determine the appropriate size of LLD based on the inside diameter of the lead coil. The Spectranetics Pin Gauges are used to determine the inner diameter of the coil. The size ofthe largest pin that fits freely in the coil indicates the size of the appropriate LLD.

3. Check patency of the coil lumen. Pass the Clearing Stylet (provided in the LLD package)
   through the inner lumen of the lead to clear any blood, coagulation, or blockage in the lumen prior to insertion of the LLD. After confirmation of a clear lumen, remove the Clearing Stylet.
   NOTE : It may be helpful to mark the depth of penetration of the Clearing Stylet into the lead by placing a mosquito clamp at that point where the Clearing Stylet exits the cut end of the lead. Knowing the depth of penetration will be useful later in monitoring progress during insertion of the LLD.

4. Grasp the appropriately sized LLD within the mesh section and advance the LLD into the inner coil of the lead, using the radiopaque marker for fluoroscopic monitoring.
   CAUTION : Do not attempt to advance or rotate the LLD via the proximal connector as premature deployment or damage to the mesh may result.
   CAUTION : Do not attempt to rotate the LLD via the proximal loop as damage to the device may result.

5. Lock the LLD in place by: Releasing the proximal connector from the crimped core mandrel by sliding the connector off the crimped section after the LLD has reached the distal end of the lead or the position indicated by the Clearing Stylet.
   This action expands the wire mesh inside the lead and locks it in place (the device is now deployed). Tension can be applied to the core mandrel or proximal loop for traction.

6. It is recommended that a suture be tied to the proximal end of the targeted lead insulation as an additional traction source. The other end of the suture can be secured to the LLD via the Distal Loop immediately above the Proximal Connector. Fastening the suture to the Distal Loop will facilitate the insertion of the LLD with the suture through the Spectranetics Laser Sheath. Closely follow the Instructions for Use for the Spectranetics Laser Sheath Kit.

7. If for some reason lead removal is unsuccessful or becomes medically contraindicated, removalor repositioning of the LLD may be facilitated as follows:
   Reset the proximal connector onto the crimped section of the core mandrel. This action reduces the diameter of the wire mesh inside the lead, unlocking it from the inner lead body.
   WARNING : Excessive applied traction forces may impact the LLD’s ability to disengage from a lead. Withdraw or reposition the LLD by grasping the proximal mesh of the locking device. If the LLD is still secured within the lead the following actions are recommended:

8. Grasp the mesh near the proximal end of the lead coil and gently smooth the mesh by stretching it towards the proximal connector.

9. Grasp the mesh again near the proximal end of the lead coil, advance the LLD within the lead and then simultaneously rotate and pull the LLD from the lead body.

Manufacturer’s Limited Warranty

Manufacturer warrants that the LLD is free from defects in material and workmanship when used by the stated “Use By” date and when package is unopened and undamaged immediately before use.  Manufacturer’s liability under this warranty is limited to replacement or refund of the purchase price of any defective LLD. Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the LLD. Damage to the LLD caused by misuse, alteration, improper storage or handling, or any other failure to follow these Instructions for Use will void this limited
warranty. THISLIMITED WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. No person or entity, including any authorized representative or reseller of Manufacturer, has the authority to extend or expand this limited warranty and any purported attempt to do so will not be enforceable against Manufacturer.Furman, S.: Removal of Implanted Hardware: PACE May 1991, Part I: 14:755 Byrd, C. L., Schwartz, S, Hedin, N.: Lead Extraction: Cardiology Clinics November 1992: 10 (4): 735-748 Epstein, A. E., et. al.: Personal and Public Safety Issues Related to Arrhythmias That May A ect  Consciousness… A Medical/Scientific Statement From the AHA and NASPE, May 10, 1994 PolicyConference  Wilko , B. L., et. al.: Seven Year Single Center Analytical Experience of Transvenous Lead Extraction. NASPE Abstract, PACE April 1996 Berstein, A., Parsonnet, V.: Pacing Practices in the United States, NASPE Abstract, PACE April 1996 Berstein, A., Parsonnet, V.: Pacing Practices in the United States (Updated), Heart Web Abstract, June1996 Helguera, M., Meierhenrich, R, Wilko , B., Morant, V., Tchou, P., Pinski, S., Cleveland Clinical Foundation: Medium-Term Performance of the Endotak Lead, NASPE Abstract, PACE April 1996
Byrd, C. L.: Extracting Chronically Implanted pacemaker Leads using the Spectranetics Excimer Laser; Initial Clinical Experience: NASPE Abstract, PACE April 1996 Byrd, C. L.: Laser System Improves Success at Removing pacemaker Leads: NASPE News Brief (Abstract#1687), PACE April 1996 Byrd, C. L.: Extraction of Telectronics 330-808 and 329-701 Leads, NASPE Abstract, PACE April 1996 Smith, H. J., et. al.: Five-Year Experience with Intravascular Lead Extraction: PACE 1994:17:2016-2020 Safety and E cacy Report on the 12 Fr Spectranetics Laser Sheath, FDA publication, July 1998
Spectranetics Laser Sheath (SLS) Instructions For Use

Non-Standard Symbols

L ead Internal Diameter Range| | Kit Includes|
---|---|---|---
Size| | Clearing Stylet Outer D iameter|
P in Gauge| | C ontents|
Q uantity| Q T Y| C oil Expander|
C aution: Federal law (USA) restricts this device to sale by or on the order of a physician.|

Rx ONLY

| Importer|

Applicable Standards

The standards identified in Table 14.1 were applied to the development of the device.

Standards applied to the development of the LLD.

Biocompatibility:
ISO 10993-1| Biological evaluation of medical devices – Part 1: Evaluation of testing
Design:
EN ISO 10555-1| Sterile, single-use intravascular catheters – Part 1: General requirements
US 21 CFR 820| Quality System Regulation
Environmental:
ISO 14644-1| Cleanrooms and associated controlled environments – Part 1: Classi cation of air cleanliness.
ISO 14644-2| Cleanrooms and associated controlled environments – Part 2: Speci cation for testing and monitoring to prove continued compliance with ISO 14644-1.
Labeling:
EN 556-1| Sterilization of Medical Devices. Requirements for medical devices to be designated “STERILE”. Requirements for terminally sterilized medical devices.
EN 980| Graphical symbols for use in labeling of Medical Devices.
EN 1041| Information supplied by the manufacturer with medical devices
ISO 15223| Medical devices Symbols to be used with medical device labels, labeling and information to be supplied
P ackaging:
EN ISO 11607-1| Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
EN ISO 11607-2| Packaging for terminally sterilized medical devices – Part 2: Valida- tion requirements for forming, sealing and assembly processes
ISO 780| Packaging – Pictorial marking for handling of goods
Q uality:
EN ISO 13485| Medical devices — Quality management systems
R isk Management:
EN ISO 14971| Medical Devices – Application of risk management to medical devices
EN 62366| Medical Devices – Application of usability engineering to medical devices
St erilization:
EN ISO 11135| Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Disposal

Use and disposal must be in accordance with generally accepted medical practice and applicable local, state, and federal laws and regulations. Products may pose a potential biohazard after use. If the packaging is damaged and / or the expiration date expires, the product is to be disposed of in ac- cordance with the rules for the treatment of medical waste class A according to SanPiN 2.1.7.2790-10. The used product is disposed of in accordance with the rules for the management of medical waste class B according to SanPiN 2.1.7.2790-10.

References

• Spectranetics | Philips

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