BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIDELITY IAB

    MDR report key: 1172390 · Received September 5, 2008

    Report

    Report Number
    1172390
    Event Type
    Death
    Date Received
    September 5, 2008
    Report Date
    September 3, 2008
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN CARDIOGENIC SHOCK REQUIRING PLACEMENT OF A TEMPORARY PACEMAKER AND INTRA-AORTIC BALLOON PUMP. SHE ALSO HAD A THROMBOSIS IN THE RIGHT COMMON FEMORAL ARTERY. WITHIN 24 HOURS OF PLACEMENT OF IABP CATHETER, BLEEDING WAS NOTED AROUND THE INSERTION SITE. ATTEMPTS TO REMOVE THE IABP CATHETER WERE MET WITH "GREAT RESITANCE". CATHETER WAS REMOVED AND IT WAS FELT THAT A PORTION OF THE BALLOON REMAINED. X-RAY OF THE PELVIS REVEALED "POSSIBLE FOREIGN BODY IN THE RIGHT FEMORAL AREA, POSSIBLE BALLOON PUMP FRAGMENT". PATIENT'S CONDITION WAS EXTREMELY CRITICAL, AND THE FAMILY ELECTED NOT TO HAVE SURGICAL PROCEDURE DONE TO REMOVE THE FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIDELITY IAB CATHETER, INTRA AORTIC BALLOON DSP DATASCOPE CORPORATION 8 FR IABP CATHETER 19461528

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death CARDIAC DRUGS| OTHER| CARDIAC DRUGS| OTHER