BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VP WIRE

    MDR report key: 2853185 · Received July 18, 2008

    Report

    Report Number
    3005007189-2008-00001
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    May 24, 2008
    Report Date
    June 18, 2008
    Manufacturer
    FLOWCARDIA, INC.
    Product Code
    DQX
    PMA / PMN Number
    K051062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ATTEMPTED RECANALIZATION OF A COMPLETELY OCCLUDED ANTERIOR TIBIAL VESSEL A FLOWCARDIA VP WIRE PERFORATED THE VESSEL. TAMPONADE WITH A 2.5MM BALLOON WAS ATTEMPTED WITHOUT SUCCESS. FOLLOWING, AN OVERSIZED STENT WAS PLACED IN THE ARTERY BUT EXTRAVASATION WAS STILL EVIDENT. COILS WERE NECESSARY TO STOP THE BLEEDING. NO RESIDUALS EFFECTS AND PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VP WIRE GUIDEWIRE DQX FLOWCARDIA, INC. 766

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention