BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES

    MDR report key: 1893522 · Received November 8, 2010

    Report

    Report Number
    2939204-2010-01033
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    June 2, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW FOR WAS PERFORMED AND SHOWED THE DEVICE MET ALL SPECIFICATIONS UPON IT RELEASE. VISUAL INSPECTION OF THE GUIDEWIRE REVEALED COATING PRESENT ON THE WIRE AND SOME AREAS WERE NOTED TO HAVE EXCESSIVE HYDROPHILIC COATING. IT WAS ALSO NOTED THAT THE PTFE COATING APPEARED TO HAVE BEEN SCRAPPED OFF WITH A SHARP OBJECT AT 103.0CM FROM ITS PROXIMAL END. THE GUIDEWIRE WAS SLIGHTLY BENT AT 50.0CM, 120.0CM 143.5CM FROM ITS PROXIMAL END AND IT WAS BENT AT 2.1CM AND 13.2CM FROM ITS DISTAL END. A WHITE COLORED SUBSTANCE WHICH APPEARED TO BE DRIED HYDROPHILIC COATING OR SALINE WAS NOTED PROXIMAL TO THE DISTAL END OF THE GUIDEWIRE. NO OTHER ANOMALIES WERE FOUND. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS OF THE DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE PTFE PEELING.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD PEELED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M00313010 B18383

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR