BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1895186 · Received November 10, 2010

    Report

    Report Number
    3005099803-2010-04695
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY OVER 18 YEARS. THE DEVICE HAS BEEN RECEIVED; HOWEVER THE EVALUATION HAS NOT YET BEEN COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE RAMP WINDOW WAS SLIGHTLY TORN BUT NO DAMAGES WERE OBSERVED ON THE WORKING LENGTH OF THE PUSH CATHETER. THE PULLWIRE WAS KINKED INSIDE THE PUSH CATHETER PROXIMAL TO THE RAMP WINDOW. DURING THE EVALUATION, THE PULLWIRE WAS REMOVED FROM THE RAMP WINDOW. THERE WERE MULTIPLE KINKS ON THE PULLWIRE NEAR THE DISTAL END OF THE PULLWIRE. THERE WERE NO ANOMALIES ON THE WELDED CANNULA/PULLWIRE. THE GUIDE CATHETER WAS DETACHED/SEPARATED FROM THE PULLWIRE AND WAS NOT RETURNED FOR EVALUATION. THE STENT WAS ALSO 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. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE RX BILIARY STENT SYSTEM WAS BACKLOADED OVER A .035" DREAMWIRE GUIDEWIRE. HOWEVER, DURING ADVANCEMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE INNER PULLWIRE EXITED OUT OF THE RX BILIARY STENT SYSTEM GUIDEWIRE EXCHANGE PORT. THE PHYSICIAN THEN ATTEMPTED TO PULL THE DELIVERY SYSTEM BACK OFF OF THE GUIDEWIRE. SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND ADDITIONAL FORCE WAS APPLIED TO THE DELIVERY SYSTEM IN ORDER TO REMOVE IT FROM THE GUIDEWIRE. AS THE PHYSICIAN PULLED THE DELIVERY SYSTEM, THE STENT DEPLOYED WITHIN THE WORKING CHANNEL OFF THE ENDOSCOPE. A SECOND RX BILIARY STENT DELIVERY SYSTEM, WITHOUT THE STENT, WAS ADVANCED OVER THE SAME DREAMWIRE GUIDEWIRE. THE ORIGINAL STENT WAS ENGAGED ONTO THE SECOND DELIVERY SYSTEM WITHIN THE ENDOSCOPE WORKING CHANNEL. THE DELIVERY SYSTEM WAS THEN USED TO SUCCESSFULLY DEPLOY THE STENT WITHIN THE COMMON BILE DUCT. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RAPID EXCHANGE BILIARY STENT SYSTEM WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A FEMALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE RX BILIARY STENT SYSTEM WAS BACKLOADED OVER A .035" DREAMWIRE GUIDEWIRE. HOWEVER, DURING ADVANCEMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE INNER PULLWIRE EXITED OUT OF THE RX BILIARY STENT SYSTEM GUIDEWIRE EXCHANGE PORT. THE PHYSICIAN THEN ATTEMPTED TO PULL THE DELIVERY SYSTEM BACK OFF OF THE GUIDEWIRE. SIGNIFICANT RESISTANCE WAS ENCOUNTERED AND ADDITIONAL FORCE WAS APPLIED TO THE DELIVERY SYSTEM IN ORDER TO REMOVE IT FROM THE GUIDEWIRE. AS THE PHYSICIAN PULLED THE DELIVERY SYSTEM, THE STENT DEPLOYED WITHIN THE WORKING CHANNEL OFF THE ENDOSCOPE. A SECOND RX BILIARY STENT DELIVERY SYSTEM, WITHOUT THE STENT, WAS ADVANCED OVER THE SAME DREAMWIRE GUIDEWIRE. THE ORIGINAL STENT WAS ENGAGED ONTO THE SECOND DELIVERY SYSTEM WITHIN THE ENDOSCOPE WORKING CHANNEL. THE DELIVERY SYSTEM WAS THEN USED TO SUCCESSFULLY DEPLOY THE STENT WITHIN THE COMMON BILE DUCT. THERE WERE NO PATIENT COMPLICATIONS.

    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 M00545680 0012695837

    Patients

    Seq Age Sex Outcome Treatment
    1