BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS

    MDR report key: 1904589 · Received November 22, 2010

    Report

    Report Number
    3005099803-2010-04924
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 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

    FROM A VISUAL EVALUATION, THE PUSH CATHETER WAS FOUND KINKED CLOSE TO PROXIMAL END AND NEAR THE RADIO OPAQUE MARKER. THE SUTURE HOLE AT THE DISTAL END WAS TORN. THE SUTURE ASSEMBLY WAS FOUND DETACHED/SEPARATED AND WAS NOT RETURNED. THE GUIDE CATHETER ASSEMBLY WAS STRETCHED AND BROKEN CLOSE TO PROXIMAL END. THE PROXIMAL BROKEN PIECE OF GUIDE CATHETER WITH THE HUB WAS NOT RETURNED FOR EVALUATION. THE DISTAL BROKEN PIECE OF GUIDE CATHETER WAS FOUND REMOVED FROM THE PUSH CATHETER ASSEMBLY. THE TORN SUTURE HOLE AND STRETCHED / BROKEN GUIDE CATHETER ASSEMBLY INDICATE THAT FORCE WAS EXERTED BY THE CUSTOMER DURING DEPLOYMENT OF STENT / RETRACTION OF THE GUIDE CATHETER ASSEMBLY. THE DISTAL END OF GUIDE CATHETER WAS FOUND TO HAVE OBVIOUS KINKS/BENDS (SUTURE IMPRESSIONS) WHICH INDICATE THAT THE SUTURE EMBEDDED INSIDE THE GUIDE CATHETER ASSEMBLY DUE TO LIKELY ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THIS MAY HAVE POTENTIALLY CAUSED STRETCHING / BREAKAGE OF THE GUIDE CATHETER ASSEMBLY. THEREFORE, BASED ON THE EVALUATION CONDUCTED THE MOST PROBABLE ROOT CAUSE 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A DRAINAGE PROCEDURE IN THE COMMON BILE DUCT OF A MALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER BECAME STRETCHED AND BROKE. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. AS THE DEVICE WAS WITHDRAWN FROM THE PATIENT, THE STENT DEPLOYED AT THE TARGET SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT SYSTEM WAS USED DURING A DRAINAGE PROCEDURE IN THE COMMON BILE DUCT OF A MALE PATIENT (PATIENT AGE AND WEIGHT ARE UNKNOWN). DURING THE PROCEDURE, THE GUIDE CATHETER BECAME STRETCHED AND BROKE. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. AS THE DEVICE WAS WITHDRAWN FROM THE PATIENT, THE STENT DEPLOYED AT THE TARGET SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION AFTER THE PROCEDURE.

    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 13549034

    Patients

    Seq Age Sex Outcome Treatment
    1