Indications, Safety and Warnings
Please see Full Prescribing Information in the IFU.
Indications for use
The D·Kaptain™* PTA High Pressure Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Contraindications
This catheter is not for use in the coronary vasculature.
Warnings
Single patient use only. Do not re-use, re-process or re-sterilize.
Potential adverse reactions
The complications that may result from a balloon dilatation procedure
include, but are not limited to:
- Allergic reaction (device, contrast medium and medications)
- Arteriovenous fistula
- Embolization (air, device, plaque, etc.)
- Hematoma
- Hemorrhage, including bleeding at puncture
- Sepsis/infection
- Thromboembolic episodes
- Vessel injury, e.g. dissection, perforation, rupture, pseudoaneurysm
- Vessel occlusion
- Vessel spasm
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.