BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGILIS¿ NXT STEERABLE INTRODUCER

    MDR report key: 8866427 · Received August 6, 2019

    Report

    Report Number
    2182269-2019-00110
    Event Type
    Death
    Date Received
    August 6, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 6, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 NOT REVIEWED AS THE BATCH NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED CARDIAC TAMPONADE AND PATIENT DEATH MAY HAVE BEEN PROCEDURE RELATED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE: 9680001-2019-00106, 2030404-2019-00068, 3005334138-2019-00430, 2030404-2019-00069. FOLLOWING AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION A CARDIAC TAMPONADE AND SUBSEQUENT PATIENT DEATH OCCURRED. DURING THE PROCEDURE NO ISSUES WERE NOTED AND BEFORE ALL CATHETERS WERE REMOVED AN INTRACARDIAC ULTRASOUND CONFIRMED THERE WAS NO TAMPONADE. HOWEVER, IN THE RECOVERY ROOM THE PATIENT BECAME HYPOTENSIVE APPROXIMATELY 4 HOURS FOLLOWING THE PROCEDURE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABILIZED, AND AN ADDITIONAL ULTRASOUND CONFIRMED THE BLEEDING HAD STOPPED. THE PATIENT EXPIRED THE NEXT DAY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659132 AGILIS¿ NXT STEERABLE INTRODUCER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, INC. G408321

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BIOSENSE WEBSTER BIDIRECTIONAL CS CATHETER| INQUIRY AFOCUS| SL1 SHEATH| TACTICATH QUARTZ ABLATION CATHETER| VIEWFLEX XTRA ICE CATHETER