EXPRESS BALLOON CATHETER

Description of Event or Problem

A SCIMED 2.5 MM EXPRESS BALLOON CATHETER MALFUNCTIONED DURING A PTCA PROCEDURE. THE BALLOON WAS PREPPED ACCORDING TO SPECIFICATIONS. THE BALLOON WAS THEN INSERTED INTO THE CIRCUMFLEX ARTERY TO THE SITE OF LESION. PHYSICIAN THEN INFLATED THE BALLOON TO THREE ATM'S. PHYSCIAN STATED HE COULD NOT SEE THE BALLOON ON FLUORO. PHYSICIAN STATED HE DID SEE AIR BUBBLES GOING DOWN THE ARTERY AT WHICH TIME HE PULLED NEGATIVE PRESSURE ON THE INFLATION DEVICE. THE INFLATION DEVICE IMMEDIATELY FILLED WITH BLOOD. THE PATIENT'S BLOOD PRESSURE DECREASED, HEART RATE DECREASED AND A TEMPORARY PACING WIRE WAS INSERTED, AND THE PATIENT WAS INTUBATED. THE PATIENT WAS PACER DEPENDENT WITH NO PRESSURE. PHYSCIAN DECIDED TO STOP CPR AND PULLED THE BALLOON BACK INTO THE GUIDE CATHETER. THE PATIENT'S BLOOD PRESSURE AND HEART RATE BEGAN TO RISE AND THE PATIENT WA PREPARED AND TAKEN TO SURGERY FOR EMERGENCY CORONARY ARTERY BYPASSDEVICE 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.