BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    MDR report key: 1161554 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04573
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SHEATH DAMAGE WAS NOTICED. THE TARGET LESION WAS IN THE COMMON BILE DUCT (CBD). A RX WS PERMALUME 10 X 60 STENT WAS IMPLANTED TO TREAT THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AT AN UNSPECIFIED TIME FOLLOWING STENT DEPLOYMENT, THE OUTER SHEATH APPEARED "DAMAGED" OR "CRACKED". 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 RX BILIARY ENDOPROSTHESIS FGE BOSTON SCIENTIFIC M00569710

    Patients

    Seq Age Sex Outcome Treatment
    1