BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON CATHETER

    MDR report key: 12770 · Received April 15, 1994

    Report

    Report Number
    MW1001608
    Event Type
    Malfunction
    Date Received
    April 15, 1994
    Date of Event
    March 24, 1994
    Report Date
    April 4, 1994
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER DILATION WITH CATHETER WAS DONE, GUIDE WIRE WAS ADVANCED THROUGH CATHETER THEN GUIDE WIRE BECAME IMMOVABLE WITHIN CATHETER. ENTIRE CATHETER AND GUIDE WIRE REMOVED WITHOUT INCIDENT. (SEE ALSO 1001632.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON CATHETER CATHETER/GUIDE WIRE LOX ADVANCED CARDIOVASCULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other