BEUDAMED
    FDA Adverse Event Summary report: N

    GUIDE WIRE

    MDR report key: 31866 · Received April 8, 1996

    Report

    Report Number
    MW1008834
    Date Received
    April 8, 1996
    Date of Event
    March 8, 1996
    Report Date
    March 25, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS,INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE DAYS AFTER A GUIDE WIRE SHEARED OFF DURING INSERTION, ANOTHER GUIDE WIRE WAS SHEARING OFF. THE WIRE WAS IMMEDIATELY REMOVED FROM THE PT WITHOUT INJURY TO THE PT. RECALL FILE NO 9634 AND 9636. (ALSO SEE 1008835)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDE WIRE GUIDE WIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS,INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR