Description of Event or Problem · 1
DURING PTCA OF CIRCUMPLEX ARTERY, A USCI FORCE 2.0 MM BALLOON CATHETER WAS USED WITH A ACS HI-TORQUE PLOPPY .014 X 300 CM WIRE. AFTER THE BALLOON WAS ADVANCED TO THE LESION, IT WAS INFLATED TO 10 ATMOSPHERES UNDER FLUROSCOPY. THE BALLOON BURST AT 1O ATMS. THE BALLOON WAS REMOVED OVER THE GUIDEWIRE. A PINHOLE WAS NOTED IN BALLOON CATHETER. PATIENT WAS ASYMPTOMATIC AND DID NOT OFFER ANY COMPLAINTSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.