BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2/14 200 CM STANDARD

    MDR report key: 1032216 · Received April 18, 2008

    Report

    Report Number
    2939204-2008-00134
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DIRECTIONS FOR USE (DFU) WARNS USERS TO: "OBSERVE ALL GUIDEWIRE MOVEMENT IN THE VESSELS USING FLUOROSCOPY. DO NOT MOVE OR TORQUE A GUIDEWIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE DISTAL GUIDEWIRE TIP; OTHERWISE, GUIDEWIRE DAMAGE, SUCH AS TIP SEPARATION, AND/OR VESSEL TRAUMA MAY OCCUR. ALWAYS ADVANCE OR WITHDRAW THE GUIDEWIRE SLOWLY AND CAREFULLY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE OF THE BRAIN, THE SUBJECT DEVICE (GUIDEWIRE) "...FRACTURED INSIDE THE MICRO CATHETER (ECHELON 10) AFTER..." THE SUBJECT DEVICE HAD BEEN TWISTED AND TURNED MULTIPLE TIMES (DISTAL TIP FRACTURE). THE PHYSICIAN HAD PRE-SHAPED THE DISTAL TIP OF THE SUBJECT DEVICE PRIOR TO USE. THE PHYSICIAN WAS ABLE TO REMOVE BOTH PARTS OF THE SUBJECT DEVICE WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED "...WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS AND THE PT IS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2/14 200 CM STANDARD DQX - WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORP. 2641 B10111

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR ECHELON MICROCATHETER (NON-BSC)