Indications
The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Contraindications
The catheter is contraindicated for use in:
- Unprotected left main coronary artery.
- Coronary artery spasm in the absence of significant stenosis.
Warnings
- For single-patient, single-procedure 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.
- Do not use the catheter if its package has been opened or damaged.
- 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.
- PTCA in patients who are not acceptable candidates for coronary artery bypass graft surgery requires careful consideration, including possible hemodynamic support during PTCA, as treatment of this patient population carries special risk.
- 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 as this can potentially result in damage to the vessel wall. If resistance is met during manipulation, determine the cause of the resistance before proceeding.
- Balloon pressure should not exceed the rated burst pressure indicated on the package label for each balloon. The rated burst pressure is based on the results of in vitro testing. Use of a pressure monitoring device is recommended to prevent overpressurization.
- PTCA should only be performed at hospitals where emergency coronary artery bypass graft surgery can be quickly performed in the event of a potentially injurious or life-threatening complication.
- Use only the recommended balloon inflation medium. To prevent the possibility of an air embolus, never use air or any gaseous medium to inflate the balloon.
- Use the catheter prior to the “Use By” date (Expiration Date) specified on the package.
Precautions
- Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the procedure for which it is to be used.
- The catheter system should be used only by physicians trained in the performance of percutaneous transluminal coronary angioplasty.
- Appropriate anticoagulation, antiplatelet, and vasodilator therapy should be administered to the patient.
- Care should be taken not to apply excessive force during preparation or use as this may damage the device.
- If the device is kinked, it should not be used.
- When inflating the balloon catheter, observe the pressure monitoring device and/or fluoroscopic image for any loss in pressure. If loss in pressure is observed, cease inflating, apply negative pressure to fully deflate the balloon, remove the balloon catheter, and inspect the system for possible leaks.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner.