BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (DQX) GUIDEWIRE

    MDR report key: 1211744 · Received October 24, 2008

    Report

    Report Number
    2939204-2008-00508
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 21, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS TO TREAT A "CAROTIS FISTULA" VIA VENOUS ENTRY THROUGH MODERATELY TORTUOUS ANATOMY. IT WAS REPORTED THAT THE FISTULA WAS QUITE SOME DISTANCE AND IT TOOK SOME TIME TO REACH THE FISTULA AND REQUIRED "LOTS OF MOVEMENTS WITH THE WIRE". ONCE THE PHYSICIAN REACHED THE FISTULA, THE DEVICE BROKE APPROXIMATELY 2.5CM FROM THE TIP. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE PIECE, BUT DOES NOT BELIEVE THAT THIS POSES A RISK TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE, AND THE PATIENT WAS REPORTED TO BE WELL POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (DQX) GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. 46-805 11922073

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ECHELON 10 MICROCATHETER (MTI)