BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY STENT

    MDR report key: 2101242 · Received May 24, 2011

    Report

    Report Number
    3005099803-2011-01887
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE UPN & LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PLANNED PROCEDURE TO REMOVE AN ADVANIX BILIARY STENT THE STENT WAS FOUND TO BE STRETCHED UPON REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL DETAILS REGARDING THE EVENT DESCRIPTION OR PATIENT CONDITION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX BILIARY STENT BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER UNK686

    Patients

    Seq Age Sex Outcome Treatment
    1