BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS ENDOSCOPIC BILIARY

    MDR report key: 1193263 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05091
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED STENTING PROCEDURE, THE ENDOSCOPIC COVERED BILIARY 8MM X 10MM STENT WAS UNABLE TO DEPLOY AT AN UNSPECIFIED LOCATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENDOPROSTHESIS ENDOSCOPIC BILIARY FGE- CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC H965431200 0011862258

    Patients

    Seq Age Sex Outcome Treatment
    1