BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿ BILIARY

    MDR report key: 2213345 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02744
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 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

    PATIENT AGE AND WEIGHT ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. (B)(4): FOR THE REPORTED EVENT OF GUIDE CATHETER BROKEN. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, 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 MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS LOADED ON THE DELIVERY SYSTEM VIA SUTURE, ALONG WITH A NON-BSC GUIDEWIRE ASSEMBLY. THE SUTURE WAS TENSED AROUND THE PROXIMAL BARB OF THE STENT BUT WAS INTACT (UNBROKEN) AND THE SUTURE HOLE ON THE PUSH CATHETER WAS TORN. THE PUSH CATHETER WAS KINKED NEAR THE HUB, THE PROXIMAL AND DISTAL BARBS OF THE STENT WERE DEPRESSED, AND THE WORKING LENGTH APPEARED DISORIENTED/DEFORMED, MOST LIKELY DUE TO CUSTOMER USAGE OF THE DEVICE. THE GUIDE CATHETER WAS FOUND STRETCHED AT THE PROXIMAL END WITH THE HUB BROKEN AND NOT RETURNED FOR EVALUATION. THE GUIDE CATHETER WAS REMOVED, WHICH REVEALED THAT THE WORKING LENGTH WAS INTACT (UNBROKEN); HOWEVER, THE STRETCHED PORTION OF THE GUIDE CATHETER WAS STUCK ON THE GUIDEWIRE ASSEMBLY. THE DISTAL TIP OF THE GUIDE CATHETER WAS TORN. THE GUIDEWIRE ASSEMBLY WAS FOUND LOADED THROUGHOUT THE LENGTH OF THE GUIDE CATHETER AND EXITED THE DISTAL TIP OF THE STENT, WHICH INDICATED THAT THE CUSTOMER DID NOT RETRACT THE GUIDEWIRE INSIDE THE DELIVERY SYSTEM OR THE ENDOSCOPE PRIOR TO DEPLOYMENT. THE INVESTIGATION CONCLUDED THAT THE STRETCHED / BROKEN GUIDE CATHETER ASSEMBLY WAS MOST LIKELY CAUSED BY FORCE EXERTED BY THE CUSTOMER DURING DEPLOYMENT OF THE STENT / RETRACTION OF THE GUIDE CATHETER ASSEMBLY. IT IS LIKELY THAT PROCEDURAL/ANATOMICAL FACTORS (PATIENT TORTUOUS ANATOMY, TIGHT STRICTURE AND/OR CUSTOMER MANEUVERING OF THE DEVICE) CONTRIBUTED TO THE DIFFICULTY IN THE DEPLOYMENT ACTIVITY, THUS LEADING TO STRETCHING / BREAKAGE OF THE GUIDE CATHETER ASSEMBLY. ADDITIONAL CONTRIBUTING FACTORS MAY ALSO INCLUDE FAILURE IN RETRACTING THE GUIDEWIRE INTO THE DELIVERY SYSTEM OR THE ENDOSCOPE BY THE CUSTOMER PRIOR TO THE DEPLOYMENT ACTIVITY AS INDICATED IN THE DIRECTIONS FOR USE (DFU). 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO FLEXIMA BILIARY STENTS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02744 ADDRESSES THE FIRST STENT, WHILE MANUFACTURER REPORT # 3005099803-2011-02752 ADDRESSES THE SECOND STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT TWO FLEXIMA BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON A MALE PATIENT ON (B)(6) 2011 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WITHDREW THE INNER CATHETER TO RELEASE THE FIRST STENT, HE MET RESISTANCE. HE CONTINUED TO WITHDRAW IT AND THE INNER CATHETER DETACHED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. THE PHYSICIAN THEN TRIED TO USE A SECOND STENT, HOWEVER HE AGAIN MET RESISTANCE WHEN ATTEMPTING TO RELEASE THE STENT. HE CONTINUED TO WITHDRAW IT AND THE INNER CATHETER DETACHED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. NO OTHER DAMAGE WAS NOTED TO EITHER DEVICE. THE TORTUOUS ANATOMY WAS REPORTED TO BE SEVERE; THEREFORE, THE PHYSICIAN DECIDED TO ABORT 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO FLEXIMA BILIARY STENTS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02744 ADDRESSES THE FIRST STENT, WHILE MANUFACTURER REPORT # 3005099803-2011-02752 ADDRESSES THE SECOND STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT TWO FLEXIMA BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON A MALE PATIENT ON (B)(6) 2011 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WITHDREW THE INNER CATHETER TO RELEASE THE FIRST STENT, HE MET RESISTANCE. HE CONTINUED TO WITHDRAW IT AND THE INNER CATHETER DETACHED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. THE PHYSICIAN THEN TRIED TO USE A SECOND STENT, HOWEVER HE AGAIN MET RESISTANCE WHEN ATTEMPTING TO RELEASE THE STENT. HE CONTINUED TO WITHDRAW IT AND THE INNER CATHETER DETACHED. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ALLOWING THE DEVICE TO BE REMOVED IN ONE PIECE. NO OTHER DAMAGE WAS NOTED TO EITHER DEVICE. THE TORTUOUS ANATOMY WAS REPORTED TO BE SEVERE; THEREFORE, THE PHYSICIAN DECIDED TO ABORT 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
    1 FLEXIMA¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539210 14393283

    Patients

    Seq Age Sex Outcome Treatment
    1