BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ SUPER STIFF GUIDEWIRE

    MDR report key: 1230218 · Received November 13, 2008

    Report

    Report Number
    2134265-2008-04345
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRAINAGE PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE ANATOMY LOCATION AND CHARACTERISTICS OF THE LESION BEING TREATED ARE UNKNOWN. THE .038 AMPLATZ SUPER STIFF GUIDE WIRE WAS INTRODUCED AND REPORTED TO HAVE "BROKE INSIDE THE PATIENT AND UNRAVELED." THE PROCEDURE OUTCOME AND PATIENT CONDITION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other