BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿ BILIARY

    MDR report key: 2213311 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02752
    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

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS LOADED ON THE DELIVERY SYSTEM VIA SUTURE. THE SUTURE WAS FOUND TENSED/TWISTED/WRAPPED AROUND THE PROXIMAL BARB OF THE STENT. THE STENT WORKING LENGTH APPEARED DISORIENTED/DEFORMED LIKELY DUE TO CUSTOMER USE. THE PUSH CATHETER WAS TWISTED/KINKED NEAR THE HUB AND AT THE MIDDLE. THE GUIDE CATHETER ASSEMBLY WAS STRETCHED AND BROKEN CLOSE TO PROXIMAL END. THE BROKEN DISTAL PIECE OF GUIDE CATHETER REMAINED INSIDE THE DELIVERY SYSTEM. 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 SUCH AS THE PATIENT'S TORTUOUS ANATOMY, CONTRIBUTED TO THE SUTURE TO TENSE/TWIST/WRAP AROUND THE PROXIMAL BARB OF THE STENT AND LEADING TO DIFFICULTY IN THE DEPLOYMENT ACTIVITY AND STRETCHING / BREAKAGE OF THE GUIDE CATHETER ASSEMBLY. THEREFORE, 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.

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. (B)(4). 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.

    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 M00539220 14270240

    Patients

    Seq Age Sex Outcome Treatment
    1