BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1678106 · Received May 10, 2010

    Report

    Report Number
    2939204-2010-00665
    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

    THE RETURNED DEVICE MEASURED 143.5CM AND THE PROXIMAL END OF THE DEVICE WAS FRACTURED. THE DEVICE WAS KINKED AT SEVERAL LOCATIONS FROM THE PROXIMAL END. THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELED NEAR A KINK IN THE DEVICE 64.5CM FORM THE 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 DURING THE PROCEDURE RESULTING IN EXCESSIVE FORCE BEING APPLIED THAT RESULTED IN THE DAMAGE TO THE PTFE COATING. SCANNING ELECTRON MICROSCOPY OF THE FRACTURE SURFACE REVEALED ELONGATED DIMPLE RUPTURES INDICATIVE OF A REVERSE BENDING ACTION THAT RESULTED IN THE FRACTURE. BASED ON THE INVESTIGATION RESULTS AND THE INFORMATION PROVIDED, THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING. THE GUIDEWIRE SEPARATION OCCURRED AS A RESULT OF FATIGUE IN A BENDING OVERLOAD DIRECTION MOST LIKELY DUE TO EXCESSIVE FORCE BEING APPLIED. THEREFORE, IT WAS CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE PTFE COATING PEELING AND THE DEVICE FRACTURE WAS OPERATIONAL CONTEXT. PMA# OR 510K#: K934122; K931584; K944677; K971254; K022357 AND K931584.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INITIAL VISUAL INSPECTION OF THE RETURNED DEVICE NOTED THAT IT HAD BROKEN ON ITS PROXIMAL SIDE AND 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 IT HAD BROKEN ON ITS PROXIMAL SIDE AND 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)