BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 991162 · Received February 4, 2008

    Report

    Report Number
    2184149-2008-00001
    Event Type
    Death
    Date Received
    February 4, 2008
    Date of Event
    January 10, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ST. JUDE MEDICAL, ESI
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE ARRAY CATHETER WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. FUNCTIONAL TESTING ON THE RETURNED ARRAY CATHETER REVEALED NO ABNORMALITIES. THE CATHETER MET SPECIFICATION RELEASE REQUIREMENTS FOR INFLATION/DEFLATION. THE CATHETER COULD BE RAISED AND LOWERED PER SPECIFICATION. ALL MECHANICAL AND FUNCTIONAL REQUIREMENTS WERE MET. THE TIP OF THE CATHETER WAS UNDAMAGED AND IN THE NORMAL PIG-TAIL SHAPE. THE GUIDE WIRE WAS ADVANCED THROUGH THE LUMEN PER SPECIFICATION REQUIREMENTS. THE CAUSE FOR THE REPORTED ARRHYTHMIA AND SUBSEQUENT PATIENT DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN POSITIONED THE ARRAY CATHETER IN THE LEFT VENTRICULAR APEX REGION. WHEN THE GEOMETRY OF THE CHAMBER WAS COLLECTED, THE GEOMETRY ORIENTATION WAS NOTED NOT TO MATCH FLUOROSCOPY VIEWS. THE PHYSICIAN POSITIONED THE TIP OF THE ABLATION CATHETER AT THE AORTIC VALVE REGION AND IT WAS AT THE LEVEL OF THE E2 ELECTRODE. THE PHYSICIAN CONSIDERED THE POSSIBILITY THAT THE E2 ELECTRODE MAY BE HIDDEN BY AN AORTIC VALVE LEAFLET. THE PHYSICIAN THEN ADVANCED THE ABLATION CATHETER OUT TO THE LV APEX AS A REFERENCE MARKER AND THEN ADVANCED THE ARRAY BALLOON TO THE SAME POSITION. GEOMETRY WAS RECOLLECTED AND DURING THIS TIME, THE GEOMETRY BECAME MISALIGNED WITH FLUOROSCOPY AGAIN. THE PHYSICIAN REPORTED THE BALLOON HAD NOT MOVED, SO HE CHOSE TO REMOVE THE BALLOON ARRAY FROM THE BODY. AT THIS TIME, THE PHYSICIAN PULLED THE BALLOON BACK TO THE MID CHAMBER REGION AND THEN ADVANCED THE SHAFT TO LOW PROFILE WHILE OBSERVING UNDER FLUOROSCOPY. ONCE IN LOW PROFILE, THE BALLOON WAS REMOVED FROM THE BODY. AFTER GROSS VISUAL INSPECTION, THE BALLOON APPEARED TO BE FULLY INTACT. THE PATIENT WAS GIVEN A HEPARIN BOLUS AND A DRIP STARTED PER THE PHYSICIAN'S ORDER TO THE PATIENT CARE NURSE. THE ACTIVATED CLOTTING TIME WAS GREATER THAN 400 SECONDS. AT THIS TIME, THE PHYSICIAN BEGAN TO PACE STIMULATE. AFTER A PERIOD OF TIME, THE PHYSICIAN WENT BACK TO THE BEDSIDE AND PERFORMED ONE RADIO FREQUENCY ABLATION APPLICATION AND THEN RETURN TO THE STIMULATOR FOR ONE MORE PACE STIMULATION. AFTER ANOTHER PERIOD OF TIME PACE STIMULATING, THE PHYSICIAN REPORTED THE PATIENT WAS IN A VENTRICULAR FLUTTER TYPE RHYTHM AND THE PATIENT CARE NURSE CHARGED THE EXTERNAL DEFIBRILLATOR AND SHOCKED. THE PHYSICIAN INITIATED "CODE" PROCEDURES AT THIS TIME; THE PATIENT EXPIRED. ADDITIONAL INFORMATION OBTAINED INDICATED THERE WAS EVIDENCE OF EFFUSION (100CC). THE PHYSICIAN STATED THAT THE EFFUSION WAS NOT CAUSED BY THE ARRAY CATHETER AND NO PERFORATION WAS NOTED. VFLUTTER BEGAN POST LV ABLATION; THE ARRAY CATHETER HAD BEEN REMOVED FROM THE LEFT VENTRICLE AT THE TIME OF THE VFLUTTER. ADDITIONAL CATHETERS USED DURING THE PROCEDURE. BOSTON SCIENTIFIC BLAZER II CATHETER (8MM) - RETROGRADE. SJM CRD2 CATHETER WAS IN THE HIS. BARD QUAD CATHETER WAS IN THE RIGHT VENTRICLE. MEDTRONIC MARINER CS CATHETER WAS IN THE CORONARY SINUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSITE MULTI-ELECTRODE ARRAY CATHETER ARRAY CATHETER DRF ST. JUDE MEDICAL, ESI NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death AND A DRIP| HEPARIN BOLUS