BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATHEROCATH, 7 FR

    MDR report key: 14468 · Received July 1, 1994

    Report

    Report Number
    MW1002684
    Event Type
    Other
    Date Received
    July 1, 1994
    Date of Event
    May 25, 1994
    Report Date
    June 15, 1994
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION, INC.
    Product Code
    MCW
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD COULD NOT SEE BALLOON WELL. REPLACED WITH ANOTHER 7 F GRAFT CUTTER, AND BALLOON WELL VISUALIZED. FELT BALLOON HAD HOLE IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH, 7 FR ATHEROCATH MCW DEVICES FOR VASCULAR INTERVENTION, INC. 14096

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other