BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANIX BILIARY STENT

    MDR report key: 2051489 · Received April 12, 2011

    Report

    Report Number
    3005099803-2011-01218
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE UPN AND LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN.THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CAN NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT SYSTEM WAS PLACED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE. THE STENT PLACEMENT TOOK PLACE DURING A PROCEDURE WHERE MULTIPLE BILIARY STENTS WERE BEING PLACED. (PATIENT AGE, SEX, WEIGHT, AND EVENT DATE ARE UNKNOWN). AS THE PHYSICIAN ATTEMPTED TO IMPLANT AN ADVANIX RX BILIARY STENT, THE ALREADY IMPLANTED BILIARY STENT WAS INADVERTENTLY PUSHED FURTHER IN TO THE DUCT. THE PHYSICIAN USED FORCEPS TO REPOSITION THIS STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION REGARDING THIS EVENT 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