BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS ENDOSCOPIC BILIARY

    MDR report key: 1203624 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05293
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: 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 THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE DEVICE FAILED TO RETRACT THE SHEATH AND THE STENT FAILED TO DEPLOY. A MODEL CVD BIL ENDO 8FR 10X80 194CM HAD BEEN ADVANCED TO TREAT A TARGET LESION IN THE COMMON BILE DUCT. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE DEVICE WAS NOT ABLE TO UNSHEATH AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED 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 9763781

    Patients

    Seq Age Sex Outcome Treatment
    1