BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY STENT

    MDR report key: 1890332 · Received November 3, 2010

    Report

    Report Number
    3005099803-2010-04729
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL RENDING, 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 TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX' BILIARY STENT WAS USED IN THE COMMON BILE DUCT OF A MALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING A STENT REMOVAL PROCEDURE, THE ADVANIX' BILIARY STENT TORE AT THE FLANGE AS IT WAS BEING REMOVED WITH A SNARE FROM THE COMMON BILE DUCT. THE REMOVAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN FINE CONDITION AFTER THE PROCEDURE. AN ERROR HAS BEEN IDENTIFIED IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX' BILIARY STENT WAS USED IN THE COMMON BILE DUCT OF A MALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING A STENT REMOVAL PROCEDURE, THE ADVANIX' BILIARY STENT TORE AT THE FLANGE AS IT WAS BEING REMOVED WITH A SNARE FROM THE COMMON BILE DUCT. THE REMOVAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN FINE CONDITION AFTER THE PROCEDURE.

    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