BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHEROCATH-GTO

    MDR report key: 22686 · Received May 25, 1995

    Report

    Report Number
    22686
    Event Type
    Malfunction
    Date Received
    May 25, 1995
    Date of Event
    May 19, 1995
    Report Date
    May 25, 1995
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION, INC.
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DCA COMPLICATED BY CUTTER MALFUNCTION AND EXTENSIVE DISSECTION AND RV INTRAMYOCARDIAL HEMATOMA AND SMALL EFFUSION. SALVAGED WITH STENTS TWICE. RH CATH PCW 13 AGAINST AND SIGNIFICANT TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH-GTO ATHERECTOMY CATHETER MCX DEVICES FOR VASCULAR INTERVENTION, INC. NA 150331

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR