BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCA-EX ATHEROCATH, 7FR

    MDR report key: 14916 · Received February 25, 1994

    Report

    Report Number
    14916
    Event Type
    Malfunction
    Date Received
    February 25, 1994
    Date of Event
    February 21, 1994
    Report Date
    February 22, 1994
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION, INC.
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CUTTER WOULD NOT ADVANCE. CUTTER CABLE SEPARATED FROM CUTTER. NO ADVERSE EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other