BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA¿ BILIARY

    MDR report key: 3021287 · Received March 26, 2013

    Report

    Report Number
    3005099803-2013-01884
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K965147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4) GUIDE CATHETER BROKEN. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM WAS RETURNED FOR EVALUATION, HOWEVER THE STENT WAS NOT RETURNED. VISUAL EVALUATION REVEALED THE PROXIMAL HUB OF THE PUSH CATHETER WAS MISSING, AND THE PUSH CATHETER PROXIMAL END WAS TORN. THE SUTURE HOLE AND SUTURE WERE FOUND TO BE INTACT AT THE DISTAL END OF THE PUSH CATHETER. THE GUIDE CATHETER WAS STRETCHED, KINKED AND BROKEN IN TWO PIECES INSIDE THE PUSH CATHETER. BOTH PIECES WERE REMOVED FROM THE PUSH CATHETER FOR INSPECTION; NO FURTHER DAMAGE WAS NOTED. THE NOTED DAMAGE INDICATES EXCESS FORCE WAS APPLIED DURING THE ATTEMPTED DEPLOYMENT AND IS LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED IN THE COMPLAINT. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) 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 DEVICE WAS USED DURING AN ERBD (ENDOSCOPIC RETROGRADE BILIARY DRAINAGE) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE TARGET SITE WAS REPORTED TO BE A TIGHT STRICTURE. DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT THE GUIDE CATHETER BROKE AND STAYED IN THE STENT. THE REST OF THE DELIVERY SYSTEM WAS REMOVED AND THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT WITH FORCEPS. THE STENT WAS LEFT IN PLACE TO COMPLETE THE PROCEDURE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT DEVICE WAS USED DURING AN ERBD (ENDOSCOPIC RETROGRADE BILIARY DRAINAGE) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(4) 2013. ACCORDING TO THE COMPLAINANT, THE TARGET SITE WAS REPORTED TO BE A TIGHT STRICTURE. DURING THE PROCEDURE, WHEN THE PHYSICIAN DEPLOYED THE STENT THE GUIDE CATHETER BROKE AND STAYED IN THE STENT. THE REST OF THE DELIVERY SYSTEM WAS REMOVED AND THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT WITH FORCEPS. THE STENT WAS LEFT IN PLACE TO COMPLETE THE PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123795 FLEXIMA¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539210

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention