BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPWIRE HYDROPHILIC GUIDE WIRE

    MDR report key: 1190577 · Received October 6, 2008

    Report

    Report Number
    2134265-2008-02911
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K000011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE SEPARATION OCCURRED. THE LOCATION AND DETAILS OF THE LESION ARE UNK. THE PHYSICIAN WAS ATTEMPTING TO INSERT THE GUIDE WIRE THROUGH A TOUHY BORST AND A THREE-WAY STOP COCK, HE MET RESISTANCE AND UPON WITHDRAWAL, HE NOTED THAT THE TIP OF THE GUIDE WIRE WAS BROKEN. THE GUIDE WIRE NEVER MADE IT INTO THE PT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT STATUS WAS REPORTED AS "UNK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIPWIRE HYDROPHILIC GUIDE WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1