BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2031849 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-00813
    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. ALTHOUGH THE LOT NUMBER IS UNKNOWN, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE SUTURE HOLE WAS TORN NEAR THE DISTAL END OF THE PUSH CATHETER. THE GUIDE CATHETER WAS STRETCHED AND BROKEN. THE GUIDE CATHETER REVEALED A SUTURE IMPRESSION MARK / KINK NEAR THE DISTAL END. THERE WAS NO DAMAGE TO THE PUSH CATHETER. THE STENT AND SUTURE WAS NOT RETURNED FOR EVALUATION. 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 BILE DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, RESISTANCE OCCURRED DURING STENT DEPLOYMENT, AND THE GUIDE CATHETER STRETCHED. THE STENT WAS DEPLOYED IN THE CORRECT POSITION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 M00539210

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: OLYMPUS'S VISIGLIDE