BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS 2000 SYNCHRO2 GUIDEWIRE

    MDR report key: 1963139 · Received January 18, 2011

    Report

    Report Number
    2939204-2011-00025
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    November 19, 2010
    Report Date
    January 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. GUIDEWIRE ANALYSIS REVEALED THAT THE PTFE COATING WAS PEELED ALONG ITS PROXIMAL END LENGTH BETWEEN 36.0CM TO 40.0CM FROM ITS PROXIMAL TIP. THE TORQUE DEVICE WAS SITUATED WHERE THE COATING HAD BEEN SCRAPPED OFF. FROM THE CONDITION OF THE GUIDEWIRE, IT APPEARED THAT THE TORQUE DEVICE HAD BEEN DRAGGED DOWN THE DEVICE SCRAPPING THE PTFE. 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 FINDING.

    Description of Event or Problem · 1

    ANALYSIS OF THE SUBJECT DEVICE REVEALED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELED OFF ALONG ITS PROXIMAL END LENGTH. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    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 M00326410 B20572

    Patients

    Seq Age Sex Outcome Treatment
    1