BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 1172145 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02719
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING PROCEDURE, INSERTION DIFFICULTIES WERE ENCOUNTERED AND WIRE BREAKAGE OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO INSERT THE AMPLATZ SUPER STIFF GUIDE WIRE INTO THE FEMORAL ARTERY, HOWEVER THE WIRE "SNAPPED". NO UNDUE FORCE WAS USED. THE AMPLATZ SUPER STIFF GUIDE WIRE THEN SNAGGED ON THE PLACEHIT WALLSTENT DELIVERY SYSTEM AND BOTH UNITS WERE REMOVED AS ONE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS WERE REPORTED, AND PT STATUS WAS REPORTED AS 'STABLE'. ADDITIONAL INFO HAS BEEN REQUESTED; HOWEVER, NONE HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZ SUPER STIFF GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA 11743570

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR