Indications, Safety and Warnings
DKutting™* PTA scoring balloon dilatation catheter
Please see Full Prescribing Information in the IFU.
Indications for use
The PTA Scoring Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Contraindications
DO NOT use the DKuttingTM* balloon:
- For passing through the struts of a previously placed stent (as the deflated PTA Scoring Balloon Dilatation Catheter could become entangled in the stent).
- For use in the coronary arteries and carotid arteries
- For the expansion or delivery of stents
Warnings
Single patient use only. Do not re-use, re-process or re-sterilize.
Potential adverse reactions
Complications from interventional treatment of stenosis with the PTA Scoring Balloon Dilatation Catheter may include, but are not limited to:
- Allergic or drug reaction (device material, contrast medium and medications)
- Amputation
- Arteriovenous fistula
- Death
- Embolism
- Hematoma
- Hemorrhage
- Hypotension/hypertension
- Infection/Sepsis
- lschemia/infarction of tissue/organ
- Pain
- Restenosis
- Surgical intervention
- Swelling
- Thrombosis
- Vascular occlusion
- Vessel injury (dissection, perforation, rupture, or Pseudoaneurysm)
- Vessel spasm
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.