Description of Event or Problem · 1
THIS 66 YEAR OLD FEMALE PATIENT WAS UNDERGOING PTCA-ANGIOPLASTY OF THE RIGHT CORONARY ARTERY. DURING A THIRD INFLATION TO A MAXIMUM PRESSURE OF 12 ATMOSPHERES AND DURING DEFLATION OF THE BALLOON, THE BALLOON RUPTURED. ALSO IN USE WAS AN ADVANCED CARDIAC SYSTEM 0.014 TRANSVERSE GUIDEWIRE. EXTENSIVE DISSECTION OF THE RIGHT CORONARY ARTERY WAS NOTED. ATTEMPTS WERE MADE TO PASS AN EXCHANGE CATHETER ACROSS THE DISSECTED SEGMENT, BUT THEY WERE UNSUCCESSFUL. THE PATIENT WAS HAVING SEVERE ISCHEMIC CHEST PAIN WITH ST ELEVATION IN THE EKG. THE PROCEDURE WAS TERMINATED, A PRE-CORDIAL BALLOON CATHETER WAS PLACED VIA THE RIGHT FEMORAL ARTERY FOR FURTHER STABLIZATION, AND THE PATIENT WAS TRANSFERRED TO THE SURGICAL SUITE FOR SURGICAL REVASCULARIZATION.DEVICE 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: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.