BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿ BILIARY

    MDR report key: 2222770 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02846
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 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

    THE DELIVERY SYSTEM AND STENT WERE RETURNED FOR EVALUATION WITH THE STENT LOOSELY LOADED ON THE DELIVERY SYSTEM. VISUAL EXAMINATION OF THE DEVICE FOUND THE SUTURE TO BE DETACHED FROM THE DELIVERY SYSTEM. THE SUTURE AND THE PROXIMAL CAP OF THE TUOHY BORST WERE NOT RETURNED. THE OUTER DIAMETER OF THE STENT WAS MEASURED AND WAS FOUND TO MEET SPECIFICATION. NO DAMAGE WAS NOTED TO THE STENT, PUSH CATHETER, OR GUIDE CATHETER ASSEMBLY; HOWEVER, THE PROXIMAL AND DISTAL BARBS OF THE STENT WERE FOUND UN-DEPRESSED. IT SHOULD BE NOTED THAT THE DIRECTIONS FOR USE (DFU) OF THIS DEVICE INDICATE AN ENDOSCOPE WITH A 4.2MM WORKING CHANNEL BE USED. IT WAS REPORTED THAT A (B)(4) SCOPE WAS USED WHICH HAS A WORKING CHANNEL OF 3.7MM AND IS NOT IN ACCORDANCE WITH THE DFU. BASED ON THE AVAILABLE INFORMATION, IT IS MOST LIKELY THAT DIFFICULTY WAS EXPERIENCED WHEN ADVANCING OR REMOVING THE DEVICE FROM THE SCOPE, LEADING TO BREAKAGE IN THE SUTURE AND PREMATURE DEPLOYMENT OF THE STENT. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS USER ERROR.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT WAS 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 EXPIRATION DATE. (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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE ENDOSCOPE WAS INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO BE ADVANCED THROUGH THE SCOPE. UPON ATTEMPTING TO REMOVE THE DEVICE FROM THE SCOPE, THE DEVICE GOT STUCK. FORCE WAS THEN APPLIED AND THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED, HOWEVER THE STENT PREMATURELY DEPLOYED AND REMAINED INSIDE THE SCOPE. THE SCOPE WAS REMOVED FROM THE PATIENT AND THE OUTER CATHETER WAS PUSHED INTO THE SCOPE IN ORDER TO REMOVE THE STENT. NO DAMAGE WAS NOTED TO THE FLEXIMA BILIARY STENT SYSTEM. THE SAME SCOPE AND ANOTHER FLEXIMA BILIARY STENT WERE USED 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 ON (B)(6) 2011 THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE ENDOSCOPE WAS INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO BE ADVANCED THROUGH THE SCOPE. UPON ATTEMPTING TO REMOVE THE DEVICE FROM THE SCOPE, THE DEVICE GOT STUCK. FORCE WAS THEN APPLIED AND THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED, HOWEVER THE STENT PREMATURELY DEPLOYED AND REMAINED INSIDE THE SCOPE. THE SCOPE WAS REMOVED FROM THE PATIENT AND THE OUTER CATHETER WAS PUSHED INTO THE SCOPE IN ORDER TO REMOVE THE STENT. NO DAMAGE WAS NOTED TO THE FLEXIMA BILIARY STENT SYSTEM. THE SAME SCOPE AND ANOTHER FLEXIMA BILIARY STENT WERE USED 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
    1 FLEXIMA¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M00539330

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE: JF 260V