BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1933939 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05109
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    October 21, 2010
    Report Date
    December 2, 2010
    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'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. A VISUAL EXAMINATION OF THE RETURNED DEVICE, REVEALED THAT THE STENT WAS LOADED ON THE DELIVERY SYSTEM VIA THE SUTURE. THE SUTURE WAS TWISTED/TENSED/WRAPPED AROUND THE PROXIMAL BARB OF THE STENT ASSEMBLY. THE PUSH CATHETER WAS KINKED, CLOSE TO PROXIMAL END NEAR THE RADIO OPAQUE MARKER. THE SUTURE HOLE AT THE DISTAL END OF THE PUSH CATHETER WAS TORN AND RIPPED THROUGH THE DISTAL TIP WHEN THE SUTURE WAS DETACHED. THE PROXIMAL BARB OF THE STENT WAS SLIGHTLY DISORIENTED BUT NO OTHER DAMAGES WERE OBSERVED ON THE STENT ASSEMBLY. THE GUIDE CATHETER ASSEMBLY WAS STRETCHED AND BROKEN CLOSE TO THE PROXIMAL END. THE DISTAL BROKEN PIECE OF GUIDE CATHETER REMAINED INSIDE THE DELIVERY SYSTEM AND WAS REMOVED FOR EVALUATION. THE DISTAL END OF GUIDE CATHETER HAD AN OBVIOUS KINK, WHICH INDICATES THAT THE SUTURE EMBEDDED INSIDE THE GUIDE CATHETER ASSEMBLY DURING RETRACTION OR DEPLOYMENT ACTIVITY. THIS MAY HAVE POTENTIALLY CAUSED STRETCHING / BREAKAGE OF THE GUIDE CATHETER ASSEMBLY DURING THE PROCEDURE WHICH COULD HAVE HINDERED THE DEPLOYMENT OF STENT. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION CONDUCTED, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUES IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE WITHIN THE INFERIOR BILE DUCT OF A PATIENT, ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE ENDOSCOPE WAS INSERTED INTO THE PATIENT; AND THEN THE STENT SYSTEM WAS ADVANCED OVER THE GUIDEWIRE WITHOUT RESISTANCE. DURING DEPLOYMENT RESISTANCE WAS ENCOUNTERED, AND THE GUIDE CATHETER STRETCHED, BUT DID NOT BREAK. AS A RESULT OF THE STRETCHED GUIDE CATHETER, THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT STENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE GOOD. THE INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS BROKEN. BASED ON THIS INFORMATION, THIS EVENT IS NOW DEEMED REPORTABLE.

    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 13370649

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE JF240| JAGWIRE