Indications For Use
The OUTBACK® Elite Re-Entry Catheter is intended to faciliate placement and positioning of guidewires and catheters within the periopheral vasculature. The OUTBACK® Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
The OUTBACK® Elite Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.
- Sterile. Sterilized with ethylene oxide gas. Nonpyrogenic. For Single use. Do not resterilize.
- This product is designed and intended for single use. It is not designed to undergo reporcessing and resterilization after initial use. Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.
- Do not expose the OUTBACK® Elite Re-Entry Catheter to organic solvents (e.g. alcohol).
- Do not use if package is opened or damanged.
- Do not use after the last day of the month of the “Use By” date on the package.
- Store in a cool dry place.
- This catheter should only be used by physicians trained in peripheral percutaneous intervetional techniques in a fully equipped catheterization laboratory.
- Do not use without completely reading and understanding this document.
- The OUTBACK® Elite Re-Entry Catheter should be kept straight during flushing, preparation steps and during guidewire loading. A sterile gauze sponge with heparinized saline may be used to wipe the catheter (with the cannula in the retracted position) going from the proximal hub to the distal tip. Do not tug or otherwise overstretch the catheter to straighten it.
- Always confirm visualization of the targeted distal vessel via contrast injection and fluoroscopy before using the catheter. Avoid contrast injection in the sub-intimal space.
- Minimize sub-intimal dissection tract beyond point of reconstitution.
- To maintain guide wire position during device exchanges, an exchangeable length guide wire is recommended.
- Prior to use, carefully read the instructions packaged with the guide wire that is to be used with the OUTBACK® Elite Re-Entry Catheter. See Table 1 for a list of recommended guide wires. Failure to use recommended guide wire may result in damage to the guide wire, such as abrasion of the hydrophilic coating, release of polymer fragments, separation of the wire, or inability to withdraw the OUTBACK® Elite Re-Entry Catheter over the guide wire.
- Always visualize tracking of the catheter tip over the aorto-iliac bifurcation.
- If strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further. Consider using 3-4 mm balloon at low ATM to dilate points of resistance, as needed, along delivery track. If the cause cannot be determined, withdraw the OUTBACK® Elite Re-Entry Catheter.
- Excessive rotation, bending or kinking of the OUTBACK® Elite Re-Entry Catheter may affect its performance. Withdraw the OUTBACK® Elite Re-Entry Catheter if it becomes excessively kinked.
- If the guide wire kinks, carefully attempt to remove the wire and replace with a new one. Stop if any resistance is felt when removing wire from the OUTBACK® Elite Re-Entry Catheter. If resistance is encountered, retract the cannula tip back into the shaft and then remove the OUTBACK® Elite Re-Entry Catheter and wire together from the vasculature.
- Excessive calcification at the site of re-entry may impair performance.
Please refer to the Instructions For Use for complete information.