BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENDOPROSTHESIS ENDOSCOPIC BILIARY

    MDR report key: 1180840 · Received September 23, 2008

    Report

    Report Number
    3005099803-2008-04763
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Report Date
    August 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 A BILIARY STENT PLACEMENT PROCEDURE, THE STEEL GUIDE BROKE DURING DEPLOYMENT. THE PHYSICIAN ADVANCED THE BILIARY STENT INTO THE COMMON BILE DUCT. WHEN THEY WERE READY TO DEPLOY THE STENT, THE NURSE WAS PULLING BACK ON THE HUB HANDLE AND THE STEEL GUIDE REPORTEDLY BROKE. IT WAS REPORTED THAT THERE WAS "LOTS OF TENSION" WHILE TRYING TO DEPLOY THE STENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1