BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX WALLSTENT BILIARY ENDOPROSTHESIS

    MDR report key: 1203637 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05297
    Event Type
    Malfunction
    Date Received
    October 16, 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
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BILIARY STENTING TREATMENT PROCEDURE, THE STENT APPEARED LONGER THAN EXPECTED. A RX WS BILIARY 10 X 60 STENT HAD BEEN ADVANCED TO TREAT TARGET LESION IN THE COMMON BILE DUCT (CBD). WHILE DEPLOYING THE STENT, THE PHYSICIAN FELT THE DEVICE APPEARED LONGER THAN 6CM. THE STENT WAS ABLE TO BE DEPLOYED WITH FINAL STENT PLACEMENT CONSIDERED TO BE "OK". THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX WALLSTENT BILIARY ENDOPROSTHESIS FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC M00569650 0011580295

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS DUODENOSCOPE