STERLING

Description of Event or Problem

IT WAS REPORTED THAT THE BALLOON BURST, REQUIRING ADDITIONAL INTERVENTION. DURING AN ANGIOGRAM AND ANGIOPLASTY OF THE LEG, A 3.0X220X90 MM STERLING BALLOON CATHETER WAS INFLATED ONCE. THE BALLOON BURST AT A PRESSURE BELOW THE RATED BURST PRESSURE. THE DEVICE WAS REMOVED FROM THE PATIENT, HOWEVER, IT WAS NOT INITIALLY RECOGNIZED THAT A PORTION OF THE BALLOON HAD SEPARATED AND REMAINED IN THE PATIENT. A CONTRAST ANGIOGRAM IDENTIFIED THE BALLOON FRAGMENT IN THE LOWER LEG. THE FRAGMENT WAS SUCCESSFULLY RETRIEVED USING A SNARE, AND ANOTHER STERLING BALLOON CATHETER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS PROLONGED DUE TO THE EVENT. NO PATIENT COMPLICATIONS WERE REPORTED, THE PATIENT WAS STABLE AND WAS DISCHARGED, AND FULLY RECOVERED.