STERLING

Additional Manufacturer Narrative

A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER. E1 - INITIAL REPORTER ADDRESS 1: (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX40MMX135CM (4F) STERLING BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION UNTIL IT REACHED 10 ATMOSPHERES. THE DEVICE WAS REMOVED USING THE NORMAL METHOD WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.