ULTRAWAND LP

Description of Event or Problem

IN 2009, TWO CV SURGEON'S PERFORMED A SURGICAL CASE TOGETHER AT A HOSPITAL. A ST. JUDE MEDICAL REPRESENTATIVE WAS PRESENT DURING THE CASE. THE PATIENT IS A FEMALE PATIENT WITH A PRIMARY SURGICAL INDICATION FOR MITRAL VALVE REPLACEMENT, CO-MORBIDITY OF OBESITY, AND ATRIAL FIBRILLATION. THE PATIENT UNDERWENT SURGERY FOR MITRAL VALVE REPLACEMENT, TRICUSPID VALVE REPAIR AND A CARDIAC ABLATION OF THE LEFT ATRIUM. THE PATIENT WAS CLINICALLY STABLE THROUGHOUT THE ENTIRE PROCEDURE AND A TRANSTHORACIC ECHO SHOWED NO BLEEDING. THE MITRAL VALVE WAS REPLACED WITH SJM EPIC TISSUE 27MM LOT# A 10249789. TRICUSPID VALVE REPAIR UTILIZED SJM TAILOR BAND 27MM LOT # 50085278/ FOR CARDIAC ABLATION PORTION: ACS # 152, ULTRACINCH 12, NO LOT # RECORDED ON FILE (NO PERMANENT IMPLANT) AND ULTRAWAND LP, NO LOT # RECORDED ON FILE (NO PERMANENT IMPLANT). THE NEXT DAY AT 10:00AM, A SJM REPRESENTATIVE RECEIVED A CALL FROM ONE OF THE SURGEONS ALERTING HIM TO THE FOLLOWING: AT 2:00AM EARLIER THIS MORNING, BLEEDING WAS IDENTIFIED BY TRANSTHORACIC ECHO AND THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM. UPON SURGICAL INSPECTION, IT WAS NOTED THAT THERE WAS A PERFORATION OF THE CARDIAC TISSUE IN THE POSTERIOR ASPECT OF THE LEFT ATRIUM, CONSISTENT WITH THE LOCATION OF THE PREVIOUS ULTRAWAND PLACEMENT AND EPICARDIALLY ADJACENT TO THE MITRAL VALVE ANNULUS AND LOCATION OF THE MITRAL VALVE REPLACEMENT. THE PATIENT IS IN THE ICU, INTUBATED AND HAS RECEIVED 8 UNITS OF BLOOD. BOTH SURGEONS AND SJM REPRESENTATIVE STATE, "THERE WAS NO CLINICAL EVIDENCE DURING THE PROCEDURE THAT THERE WAS A CARDIAC BLEED". THE PATIENT LEFT THE OPERATING ROOM CLINICALLY STABLE AND THERE WERE NO REMARKABLE FINDINGS WITH THE ULTRAWAND LP DEVICE. THE DEVICE WAS USED PER GUIDELINES AND WITHIN EXPECTED OPERATING PARAMETERS. THE ABLATION CONTROL SYSTEM RECORDS WERE OBTAINED BY THE REP AND DELIVERED TO SJM FOR REVIEW. THE ENTIRE SURGICAL CASE WAS REVIEWED AND THE CASE RECORDS INDICATE THAT THE ULTRAWAND LP DEVICE FUNCTIONED WITHIN OPERATING PARAMETERS, CONSISTENT WITH ROUTINE DEVICE PERFORMANCE. ALL TEMPERATURES WERE WITHIN SPECIFICATIONS AND THE FLOW RATE FOR THE IV INFUSION PUMP WAS SET TO DELIVER 360ML DURING THE PROCEDURE. NO REMARKABLE EVENTS WERE NOTED. THE ULTRAWAND LP UNIT WAS DISPOSED OF AT THE SITE, FOLLOWING THE PROCEDURE, DUE TO NO COMPLICATIONS DURING THE CLINICAL PROCEDURE. THE ULTRAWAND LP DEVICE, DUE TO THE DISPOSAL, IS UNAVAILABLE FOR FAILURE ANALYSIS. THE PROCEDURE PERFORMED REQUIRES MANIPULATION OF THE HEART AS THE ULTRACINCH IS PLACED ON THE POSTERIOR ASPECT OF THE LEFT ATRIUM, AS IS THE ULTRAWAND LP. THESE DEVICES ARE ALSO PLACED ADJACENT TO THE MITRAL VALVE ANNULUS. THE CHIEF CARDIAC SURGEON AT ANOTHER FACILITY, WORKING ON BEHALF OF ST. JUDE MEDICAL CONTACTED ONE OF THE SURGEONS CONCERNING THIS SURGICAL CASE THREE DAYS LATER. THE DOCTORS DISCUSSED THE CLINICAL ASPECTS OF THE PATIENT AND THE USE OF THE ULTRAWAND LP DURING THE PROCEDURE. THE SURGEON STATED, DURING THE DISCUSSION, HE FOLLOWED THE IFU TO COMPLIANCE. THE TEMPERATURES, PRESSURE AND FLOW RATE WERE ALL WITHIN ROUTINE PRODUCT SPECIFICATIONS. IN ADDITION, THE ABLATION CONTROL SYSTEM RECORDINGS OF THE PROCEDURE WERE ALL WITHIN NORMAL OPERATING PARAMETERS. THE PATIENT UNDERWENT MULTIPLE PROCEDURES INCLUDING AN ULTRACINCH, CARDIAC ABLATION, MITRAL VALVE REPLACEMENT, TRICUSPID VALVE REPAIR AND CARDIAC PACING. HOSPITAL INVESTIGATION REVEALS THAT WHEN THE CARDIAC PACING LEAD WAS PLACED, A HEMATOMA FORMED A 1 TO 2 CM FROM THE PREVIOUS CARDIAC ABLATION SITE AND EPICARDIALLY ADJACENT TO THE MITRAL VALVE REPAIR. THE SURGEON, AT THIS TIME DOES NOT FEEL THE PATIENT'S CARDIAC BLEED WAS INDUCED BY THE ULTRAWAND PLACEMENT. ST JUDE MEDICAL IS CONTINUING TO INVESTIGATE ALL ASPECTS OF THIS SURGICAL CASE AND DEVICE PERFORMANCE.