BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE WHISPER MS

    MDR report key: 1102303 · Received July 30, 2008

    Report

    Report Number
    1102303
    Event Type
    Death
    Date Received
    July 30, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 30, 2008
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    PRIOR TO THIS EVENT, THE PATIENT WAS ADMITTED TO OUR HOSPITAL TO UNDERGO A CARDIAC CATHETERIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS DETERMINED THAT THE PATIENT WOULD REQUIRE A CARDIAC STENT. DURING PLACEMENT OF THE STENT, THE TIP OF THE GUIDE WIRE BROKE OFF AND WAS NOT RETRIEVED. SINCE THERE WAS NO PATIENT INJURY OR ILLNESS, A VOLUNTARY MEDWATCH REPORT WAS FILED. SUBSEQUENT TO FILING OF THIS REPORT, WE BECAME AWARE THAT THE PATIENT PRESENTED TO OUR ER A FEW DAYS LATER COMPLAINING OF CHEST PAIN. THE PATIENT BECAME UNRESPONSIVE AND SUBSEQUENTLY EXPIRED. THIS SECOND REPORT IS BEING FILED AS A FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDEWIRE DQX ABBOTT VASCULAR DEVICES * 8030691

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death