BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE

    MDR report key: 9720001 · Received February 18, 2020

    Report

    Report Number
    3008452825-2020-00088
    Event Type
    Death
    Date Received
    February 18, 2020
    Date of Event
    January 27, 2020
    Report Date
    February 18, 2020
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA (AFD)
    Product Code
    DRF
    UDI-DI
    05414734201360
    PMA / PMN Number
    K002976
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION AND SUBSEQUENT PATIENT EXPIRATION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING A CRT-D IMPLANTATION PROCEDURE A CARDIAC TAMPONADE AND SUBSEQUENT PATIENT EXPIRATION OCCURRED. THE DIAGNOSTIC CATHETER WAS USED FOR CORONARY SINUS (CS) CANNULATION. WHILE IMPLANTING THE LEADS THERE WAS DIFFICULTY ADVANCING PAST THE CS BUT EVENTUALLY THE LEADS WERE ABLE TO OVERPASS THE VALVE. ONCE PAST THE VALVE THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED BLOOD IN THE PERICARDIUM. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT HOWEVER CARDIOPULMONARY RESUSCITATION WAS NEEDED. THE PATIENT EXPIRED FOLLOWING INTERVENTION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186270 SUPREME¿ ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, CRD¿ CURVE, ELE CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, COSTA RICA LTDA (AFD) 401442 7219617 05414734201360

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death