MUSTANG?

Description of Event or Problem

IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AORTA. A 7.0 X 100, 135CM MUSTANG BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

Additional Manufacturer Narrative

A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER. D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). G4 - PREMARKET / 510(K) #: K141521, K141597.