Quick-Cross SELECT P017738-00 Catheter Instruction Manual

Quick-Cross SELECT P017738-00 Catheter

DESCRIPTION

The Spectranetics Quick-Cross Select Support Catheters are intravascular catheters. These catheters are available in a variety of lengths and tip configurations. All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating.

INDICATIONS FOR USE

Quick-Cross Select Support Catheters are intended to guide and support a guidewire during access of the coronary or peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

CONTRAINDICATIONS

None known.

WARNINGS

• Maximum Infusion Pressure: 300 psi. for 0.014” & 0.018” catheters and 500 psi for 0.035” catheters.
• The catheter is designed and intended for one time use only. Do not re-sterilize and/or reuse.
• The catheter should only be used by physicians qualified to perform percutaneous vascular interventions.

PRECAUTIONS

• 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 if device or packaging is damaged.
• Use the catheter prior to the “Use By” date (Expiration Date) specified on the package.

ADVERSE EFFECTS

Vascular catheterization and/or vascular intervention may result in complications including but not limited to:

• Vessel dissection, perforation, rupture or total occlusion
• Infection
• Hematoma
• Unstable angina
• Embolism
• Hypo/hypertension
• Acute myocardial infarction
• Arrhythmia, including ventricular fibrillation
• Death

HOW SUPPLIED

This device has been sterilized using Ethylene Oxide and is supplied STERILE. The devices are designated and designed for SINGLE USE ONLY and must not be resterilized and/or reused.
Sterilization

• The sterility of the product is guaranteed only if the package is unopened and undamaged. Before use, visually inspect the sterile package to ensure that the seals have not been broken. Do not use the catheter if the integrity of the package has been compromised. Do not use catheter if its “Use Before Date,” found on-package labeling, has been passed.

Transportation and Storage

• Keep dry. Store in a cool dry place. Protect from direct sunlight and high temperature (greater than 55°C or 131°F).

Inspection prior to use

• Before use, examine carefully for defects, all of the equipment to be used. Do not use any equipment if it is damaged or unintentionally opened

COMPATIBILITY

Mode (Ref)

| ****

Working Length

| ****

Tip Shape / Type

| ****

Hydrophilic Coating Length

| ****

GW

Compatibility

| ****

Min. Guide

.D

| ****

Min.

Sheath I.D.

| ****

Maximum Catheter O.D.

| Marker Band Spacing| ****

Throw Angle

---|---|---|---|---|---|---|---|---|---

518-08

| ****

35 cm

| ****

Angled

| ****

00 cm

| ****

0.014”

0.36 mm

| ****

5F

| ****

4F

| 3.2F

0.042”

.07 mm

| ****

5 mm

| ****

45°

518-087

| ****

50 cm

| ****

Angled

518-089| 90 cm| Angled| 60 cm| ****

0.018”

0.46 mm

| ****

5F

| ****

4F

| 3.4F

0.044”

.12 mm

| ****

5 mm

| ****

45°

518-09| 35 cm| Angled| ****

00 cm

518-09| 50 cm| Angled
518-077| 65 cm| Angled| 45 cm| ****

0.035”

0.89 mm

| ****

N/A

| ****

5F

| 4.5F

0.059”

.50 mm

| ****

50 mm

| ****

45°

518-079| 90 cm| Angled| 0 cm
518-08| 35 cm| Angled| 15 cm
518-08| 50 cm| Angled| 30 cm

PROCEDURE SET-UP AND DIRECTIONS FOR USE

Note: Follow instructions for use for all equipment to be used with the Quick-Cross Select Support Catheter.

1.   Preparation: Using the sterile technique, open the sterile package. Gently remove the protective hoop with the catheter from the pouch. Fill a sterile standard luer-lock syringe with sterile saline. Before removing the catheter from the hoop, connect the syringe to the catheter proximal Luer fitting, fl ush the catheter and allow the saline to fi ll the hoop. Set catheter in hoop aside until ready for use.
2. Insertion: Through a previously inserted, appropriately sized guiding catheter or introducer sheath, introduce the catheter over an appropriately sized guidewire (see specifications) using standard technique.
3.  Advancement: Use fluoroscopic guidance when advancing the catheter to the desired location within the vasculature.
4. Removal: Gently withdraw the catheter using standard technique, being careful to maintain guidewire position if the guidewire is to remain in place.
   Infusion: To perform infusion, withdraw the guidewire and reference the specifications for maximum infusion pressure.
   Note: Do not exceed the maximum infusion pressures. After use, dispose of all equipment in accordance with applicable requirements relating to hospital waste, and potentially bio-hazardous materials.

MANUFACTURER’S LIMITED WARRANTY

Manufacturer warrants that the Quick-Cross Select 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. The manufacturer’s liability under this warranty is limited to replacement or refund of the purchase price of any defective Quick-Cross Select. Manufacturer will not be liable for any incidental, special, or consequential damages resulting from use of the Quick-Cross Select. Damage to the Quick-Cross Select caused by misuse, alteration, improper storage or handling, or any other failure to follow these Instructions for Use will void this limited warranty. THIS LIMITED 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 the Manufacturer, has the authority to extend or expand this limited warranty and any purported attempt to do so will not be enforceable against Manufacturer.

NON-STANDARD SYMBOLS

APPLICABLE STANDARDS

The standards identified in Table 12.1 were applied to the development of the device.
Table 12.1: Standards applied to the development of the Quick-Cross Select.

Biocompatibility:
ISO 10993-1| Biological evaluation of medical devices – Part 1: Evaluation of testing
Clinical Study:
EN ISO 14155| Clinical Investigation of medical devices for human subjects
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: Classification of air cleanliness.
ISO 14644-2| Cleanrooms and associated controlled environments – Part 2: Specification 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
Packaging:
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: Validation requirements for forming, sealing and assembly processes
ISO 780| Packaging – Pictorial marking for handling of goods
Quality:
EN ISO 13485| Medical devices — Quality management systems
Risk Management:
EN ISO 14971| Medical Devices – Application of risk management to medical devices
EN 62366| Medical Devices – Application of usability engineering to medical devices
Sterilization:
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 accordance 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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