BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 2231470 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02844
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 10, 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 DELIVERY SYSTEM AND STENT WERE RETURNED FOR EVALUATION WITH THE STENT SEPARATED FROM THE DELIVERY SYSTEM. VISUAL EVALUATION OF THE DEVICE WAS PERFORMED. NO DAMAGE WAS NOTED TO THE STENT. THE SUTURE WAS FOUND INTACT AND FREE OF DAMAGE AT THE DISTAL END OF THE PUSH CATHETER. THE SUTURE HOLE ON THE PUSH CATHETER WAS FOUND TO BE TORN. THE PROXIMAL HUB OF THE PUSH CATHETER AND THE TOUHY BORST ASSEMBLY WERE FOUND DETACHED AND WERE NOT RETURNED FOR EVALUATION. MARKINGS ON THE PUSH CATHETER WERE NOTED, INDICATING THE HUB WAS INITIALLY INTACT; THE HUB MOST LIKELY DETACHED DURING USE. THE GUIDE CATHETER ASSEMBLY WAS FOUND STRETCHED AND BROKEN NEAR THE PROXIMAL END THE DISTAL END OF THE GUIDE CATHETER WAS REMOVED FROM THE PUSH CATHETER ASSEMBLY FOR OBSERVATION; KINKS AND BENDS (SUTURE IMPRESSIONS) WERE NOTED INDICATING THE SUTURE EMBEDDED INSIDE THE GUIDE CATHETER ASSEMBLY DURING STENT DEPLOYMENT. THE STRETCHED AND BROKEN GUIDE CATHETER INDICATED THAT FORCE WAS EXERTED DURING DEPLOYMENT OF THE STENT. 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 WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC BILIARY DRAINAGE (EBD) PROCEDURE OF THE COMMON BILE DUCT (PROCEDURE DATE, AND PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, RESISTANCE WAS MET AND THE STENT FAILED TO DEPLOY. IT WAS REPORTED THAT THE GUIDE CATHETER STRETCHED, HOWEVER NO OTHER DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. 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 IN TWO PIECES, 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 M00539210 14024798

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE:JAGWIRE| ENDOSCOPE: JF-260V