BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2031657 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-00789
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY (B)(6). THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS ATTACHED TO THE DELIVERY SYSTEM VIA THE INTACT AND UNBROKEN SUTURE. THE PUSH CATHETER WAS KINKED AT THE PROXIMAL END. THE SUTURE HOLE WAS SLIGHTLY TORN. THE GUIDE CATHETER WAS STRETCHED AND BROKEN. THE PROXIMAL END OF THE GUIDE CATHETER WAS NOT RETURNED FOR EVALUATION. THE DISTAL END OF THE GUIDE CATHETER WAS COLLAPSED. THERE WAS NO DAMAGE TO THE STENT. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT AS THE SUTURE DETACHED FROM THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER A FLEXIMA BILIARY STENT SYSTEM WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; BROKEN GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539260

    Patients

    Seq Age Sex Outcome Treatment
    1