BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2231441 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02879
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 12, 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

    PATIENT AGE AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION WITH THE STENT LOADED ON THE DELIVERY SYSTEM VIA SUTURE. VISUAL EVALUATION WAS PERFORMED. NO DAMAGES WERE NOTED TO THE STENT. THE SUTURE HOLE ON THE PUSH CATHETER WAS FOUND TO BE TORN. THE WORKING LENGTH OF PUSH CATHETER WAS FOUND KINKED AT SEVERAL LOCATIONS. THE GUIDE CATHETER ASSEMBLY WAS FOUND STRETCHED AND BROKEN NEAR THE PROXIMAL END. THE DISTAL BROKEN PIECE OF GUIDE CATHETER REMAINED INSIDE THE DELIVERY SYSTEM. THE SUTURE WAS SEPARATED FROM THE DELIVERY SYSTEM IN ORDER TO OBSERVE THE DISTAL END OF THE GUIDE CATHETER. THE DISTAL END OF GUIDE CATHETER WAS FOUND TO HAVE MULTIPLE, MINOR KINKS AND BENDS (SUTURE IMPRESSIONS) WHICH INDICATE THE SUTURE LIKELY EMBEDDED INSIDE THE GUIDE CATHETER ASSEMBLY DURING ATTEMPTED DEPLOYMENT. THE STRETCHED AND BROKEN GUIDE CATHETER INDICATE FORCE WAS EXERTED WHEN THE STENT WAS ATTEMPTED TO BE DEPLOYED. THE NOTED DEFECTS ARE LIKELY DUE TO PROCEDURAL OR ANATOMICAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS PATIENT TORTUOUS ANATOMY AND/OR CUSTOMER MANEUVERING OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A BILIARY DRAINAGE PROCEDURE OF THE COMMON BILE DUCT PERFORMED ON A MALE PATIENT ON (B)(6), 2011 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SUTURE WOULD NOT RELEASE AND THE STENT FAILED TO DEPLOY. NO DAMAGE WAS NOTED TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. INVESTIGATION RESULTS REVEALED THE GUIDE CATHETER TO BE BROKEN, THEREFORE THIS IS NOW AN MDR REPORTABLE EVENT.

    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 M00539200 13966246

    Patients

    Seq Age Sex Outcome Treatment
    1