BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS 2000 SYNCHRO2 GUIDEWIRE

    MDR report key: 1911158 · Received November 30, 2010

    Report

    Report Number
    2939204-2010-01106
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GUIDEWIRE ANALYSIS REVEALED PEELING OF THE PTFE COATING AT 41.0CM TO 44.0CM FROM ITS PROXIMAL END. THE TORQUE DEVICE WAS SITUATED WHERE THE COATING HAD BEEN SCRAPPED. FROM THE CONDITION OF THE GUIDEWIRE, THE PTFE COATING APPEARED TO BE SCRAPPED OFF OF WITH THE TORQUE COLLET. NO DEFECTS WERE OBSERVED ON THE GUIDEWIRE DISTAL END AND NO ANOMALIES WERE OBSERVED WITH THE HYDROPHILIC COATING. FROM THE CONDITION OF THE PTFE PEELING, IT APPEARS THAT THE TORQUE DEVICE WAS NOT SECURELY FASTENED ONTO THE WIRE AND HAD BEEN DRAGGED ALONG ITS BODY CAUSING THE PEELING. THE DIRECTIONS FOR USE (DFU) CAUTIONS THAT INSUFFICIENT TIGHTENING OF THE TORQUE CAN LEAD TO PTFE PEELING. THEREFORE, A ROOT CAUSE OF USE/USER ERROR HAS BEEN ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    ANALYSIS OF THE SUBJECT DEVICE REVEALED THAT THE POLYTETRAFLUOROETHYLENE TUBING (PTFE) COATING WAS PEELED OFF ALONG ITS PROXIMAL END LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVS 2000 SYNCHRO2 GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M00326010

    Patients

    Seq Age Sex Outcome Treatment
    1