GLADIATOR? ELITE

Description of Event or Problem

IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERY AND VEIN OF UPPER LIMB. A 4.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 26 ATMOSPHERES, THE BALLOON RUPTURED. AFTER THE PHYSICIAN CHECKED THE BLOOD VESSEL, THE BALLOON DILATATION PASTE WAS WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

Additional Manufacturer Narrative

E1 - INITIAL REPORTER FACILITY NAME: XINFENG COUNTY HOSPITAL OF TRADITIONAL CHINESE MEDICINEE1 - INITIAL REPORTER ADDRESS 1: NO. 52, SHENGLI WEST ALLEY, JIEFANG STREET, JIADING TOWN, XINFENG COUNTYE1 - INITIAL REPORTER PHONE: +011(086)13755812864