BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS ENDOSCOPIC BILIARY

    MDR report key: 1193216 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05097
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, DEVICE DAMAGE OCCURRED. THE PHYSICIAN WAS ATTEMPTING TO PLACE A 10 X 40 ENDOPROSTHESIS ENDOSCOPIC BILIARY WALLSTENT. WHEN THE PHYSICIAN ATTEMPTED TO RELEASE THE STENT, SEVERE RESISTANCE WAS MET AND THE T-BAR BROKE, FAILING TO RELEASE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BILIARY WALL STENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS ENDOSCOPIC BILIARY FGE BOSTON SCIENTIFIC H965431000 8988298

    Patients

    Seq Age Sex Outcome Treatment
    1