BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1678105 · Received May 10, 2010

    Report

    Report Number
    2939204-2010-00664
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    March 2, 2010
    Report Date
    April 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K934122; K931584; K944677; K971254; K022357 AND K931584.PENDING FULL ANALYSIS OF THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED GUIDEWIRE NOTED THE DEVICE WAS KINKED AND THE POLYTETRAFLUOROETHYLENE (PTEF) COATING WAS PEELED AT 55.3, 56 AND 56.9CM FROM ITS PROXIMAL END. AN ADHESION TEST CONFIRMED THERE WAS PROPER ADHESION OF THE COATING. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION RESULTS, THE TORTUOUS ANATOMY MAY HAVE CAUSED A HIGH FRICTION ENCOUNTERED DURING THE PROCEDURE. SUBSEQUENTLY, THE PHYSICIAN MAY HAVE APPLIED EXCESSIVE FORCE TO OVERCOME RESISTANCE, WHICH COULD HAVE CAUSED THE DAMAGE TO THE PTFE COATING OF THE GUIDEWIRE. AS TORTUOUS ANATOMY AND FRICTION ARE CONSIDERED TO BE PROCEDURAL FACTORS, THEREFORE; A ROOT CAUSE OF OPERATIONAL CONTEXT HAS BEEN ASSIGNED TO THE EVENT.

    Description of Event or Problem · 1

    INITIAL VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING ON THE GUIDEWIRE HAD BEEN PEELED OFF ON SEVERAL PLACES ALONG ITS LENGTH. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    INITIAL VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING ON THE GUIDEWIRE HAD BEEN PEELED OFF ON SEVERAL PLACES ALONG ITS LENGTH. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI UNK532

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)| NEUROFORM STENT SYSTEM (BOSTON SCIENTIFIC)