BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATHEROCATH

    MDR report key: 12122 · Received March 18, 1994

    Report

    Report Number
    MW1001156
    Event Type
    Malfunction
    Date Received
    March 18, 1994
    Date of Event
    January 20, 1994
    Report Date
    March 2, 1994
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN DEVICE WAS USED, NOSECONE WOULD NOT FLUSH. THE GUIDE WIRE CAME OUT OF THE SIDE OF THE NOSECONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH CATHETER MCX DEVICES FOR VASCULAR INTERVENTION 6F.EX (EX 60-09)

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other