BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSITE MULTI-ELECTRODE ARRAY CATHETER

    MDR report key: 1078611 · Received July 21, 2008

    Report

    Report Number
    2184149-2008-00008
    Event Type
    Death
    Date Received
    July 21, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ST. JUDE MEDICAL ESI
    Product Code
    DRF
    PMA / PMN Number
    K983456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ST. JUDE MEDICAL IS IN THE PROCESS OF INVESTIGATING THIS EVENT. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A LEFT VENTRICULAR V-TACH ABLATION WAS BEING PERFORMED WITH AN UNK ABLATION CATHETER. THE PHYSICIAN CONCURRENTLY USED AN ENSITE ARRAY CATHETER FOR MAPPING. AFTER INITIAL PLACEMENT OF THE ARRAY INTO THE LEFT VENTRICLE BY WAY OF RETROGRADE AORTIC APPROACH, THE USER CONTINUOUSLY EXPERIENCED IMPROPER ABLATION CATHETER LOCATION ON THE ENSITE SYSTEM. IT WAS DETERMINED THAT THIS WAS CAUSED BY THE DISTAL E1 ELECTRODE ON THE ARRAY, WHICH WAS TUCKED UNDER THE PAPILLARY MUSCLE THEREFORE INHIBITING THE LOCATOR SIGNAL TO THE ABLATION CATHETER. THE ARRAY WAS REPOSITIONED SEVERAL TIMES WITH NO SUCCESS IN ACHIEVING CORRECT ABLATION CATHETER DISPLAY ON THE ENSITE SYSTEM. ACCORDINGLY, THE ENSITE SYSTEM WAS NOT USED TO DETERMINE THE LOCATION OF THE ABLATION. THE ARRAY CATHETER HOWEVER, WAS LEFT IN PLACE THROUGH THE DURATION OF THE PROCEDURE. THE PHYSICIAN CONTINUED WITH THE ABLATION USING THE CONVENTIONAL METHOD OF USING ONLY FLUOROSCOPY AND INTRACARDIAC ELECTROGRAMS. SHORTLY AFTER SEVERAL ABLATION LESIONS WERE PLACED. THE PT SUFFERED A CARDIAC TAMPONADE. A PERICARDIAL TAP WAS PERFORMED AND THE PT WAS IN SERIOUS BUT STABLE CONDITION UPON LEAVING THE LAB. THE ARRAY CATHETER WAS NOT RETAINED OR RETURNED FO ST. JUDE MEDICAL (SJM) FOR ANALYSIS. THE SJM FIELD CLINICAL ENGINEER WAS INFORMED IN 2008 THAT THE PT EXPIRED SEVERAL DAYS POST PROCEDURE DUE TO A STROKE. THE CAUSE OF THE STROKE IS EITHER UNK/UNDETERMINED AT THIS POINT. THE SJM FIELD CLINICAL ENGINEER INDICATED THAT THE PHYSICIAN DID NOT ALLEGE THAT THE EITHER THE ENSITE SYSTEM OR ENSITE ARRAY CATHETER CONTRIBUTED TO THE ADVERSE EVENT.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| O