The POWERFLEX® PRO PTA Catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilation of balloon-expandable and self-expanding stents in the peripheral vasculature.
- None known for PTA procedure.
- The POWERFLEX® PRO PTA catheter is contraindicated for use in coronary arteries.
- This device is intended for one time use only.
- DO NOT resterilize and/or reuse it, as this can potentially result in compromised device performance and increased risk of inappropriate resterilization and cross contamination.
- To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.
- When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.
- Do not advance or retract the catheter unless the balloon is fully deflated under vacuum.
- If resistance is met during manipulation, determine the cause of the resistance before proceeding.
- Balloon pressure should not exceed the rated burst pressure. The rated burst pressure is based on the results of in vitro testing. At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure. Use of a pressure monitoring device is recommended to prevent over pressurization.
- Use only the recommended balloon inflation medium. Never use air or any gaseous medium to inflate the balloon.
- Use the catheter prior to the “Use By” date specified on the package.
- Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
- The catheter system should be used only by physicians trained in the performance of arteriography and who have received appropriate training in percutaneous transluminal angioplasty.
- Consider the use of systemic heparinization. Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution.
- The minimal acceptable sheath French size is printed on the package label. Do not attempt to pass the PTA catheter through a smaller size sheath introducer than indicated on the label.
Possible adverse effects include, but are not limited to, the following:
- Air embolism
- Hematoma at the puncture site
- Perforation of the vessel wall
- Vascular Complications (e.g. intimal tear, dissection, pseudoaneurysm, perforation, rupture, spasm, occlusion)
- Allergic reaction (device, contrast medium and medications)
- Pyrogenic reaction
- Hemorrhage, including bleeding at puncture site
- Hypotension / hypertension