Prescriptive Information
Untitled Document
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Contraindications
2cm Peripheral Cutting Balloon Device: The Peripheral Cutting Balloon Device is not for use in coronary arteries or carotid arteries. The Peripheral Cutting Balloon Device is not intended for the expansion or delivery of stents. Peripheral Cutting Balloon: small Monorail and Over-the-Wire Delivery Systems (0.014" system): The Peripheral Cutting Balloon Device is not for use in the carotid arteries. The Peripheral Cutting Balloon Device is not intended for the expansion or delivery of stents.
Warnings
- Contents supplied STERILE using a radiation process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.
- For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- Angioplasty with the Peripheral Cutting Balloon Device, because of its mechanism of action, may pose a greater risk of perforation than that observed with conventional PTA. Oversizing increases the risk of perforation. To reduce the potential for vessel damage, the inflated diameter of the Peripheral Cutting Balloon Device should not exceed a 1.1:1 ratio to 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.
- Do not advance the guide wire or the Peripheral Cutting Balloon Device if the sheath is kinked, buckled or offers resistance. Resistance, kinking, or buckling in the introducer sheath may damage the atherotomes or balloon; a tight sheath can press the balloon material against an atherotome with sufficient force to puncture the balloon. If resistance is encountered when removing the catheter through an introducer sheath or a guide wire through the catheter, stop and remove them as a complete unit to prevent damage to the guide wire, catheter, introducer sheath, or vessel. After removal from the introducer sheath, do not re-insert the Peripheral Cutting Balloon Device.
- 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 pressure. Use of a pressure monitoring device is recommended to prevent over pressurization.
- Use only the recommended balloon inflation medium (e.g. contrast medium). Never use air or any gaseous medium to inflate the balloon.
- Use the catheter prior to the Use Before date specified on the package. Apply minimal dilating force to minimize risks of balloon over-inflation or rupture.
Potential Adverse Effects
None
Cautions
- 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.
- Only physicians who have received the appropriate training by Boston Scientific should use the Peripheral Cutting Balloon Device.
- During the procedure, appropriate anticoagulant therapy should be provided to the patient. Anticoagulant therapy should be continued after the procedure for a period of time to be determined by the physician.
- The Cutting Balloon Device is not designed for, and therefore, cannot be used to monitor in vivo arterial pressures.
Trademark
Cutting Balloon is a trademark of Boston Scientific Corporation or its affiliates.
