Description of Event or Problem · 1
ON 9/29/93, THE PT UNDERWENT CORONARY ARTERY BYPASS GRAFT SURGERY. POST-OPERATIVELY THE PT HAD AN UNSTABLE COURSE INCLUDING BLEEDING, WIDE VARIATIONS IN BLOOD PRESSURE DESPITE VASOPRESSORS, RENAL FAILURE AND SEVERE MITRAL REGURGITATION. ON 10/1/93, AN INTRA-AORTIC BALLOON WAS INSERTED WITHOUT COMPLICATION STABILITY. FOUR HRS LATER, SPONTANEOUS RUPTURE OF THE BALLOON OCCURRED. A SUBSEQUENT ATTEMPT AT INSERTING A BALLOON INTO THE RIGHT FEMORAL ARTERY WAS UNSUCCESSFUL. THE PT WAS THEN TAKEN TO THE OR FOR AN OPEN INSERTION OF AN INTRA-AORTIC BALLOON. DURING THIS PROCEDURE, THE PT EXPERIENCED WIDE VARIATIONS IN BLOOD PRESSURE, ATRIAL ARRYTHMIAS, PROFOUND HYPOTENSION, VENTRICULAR FIBRILLATION AND ARREST. THE PT EXPIRED DESPITE RESUSCITATIVE MEASURES.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.