BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3213254 · Received July 9, 2013

    Report

    Report Number
    3005099803-2013-06670
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4) FOR THE EVENT OF HANDLE CANNULA DETACHED. 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

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE HANDLE CANNULA DETACHED. THE HANDLE CANNULA PRESENTED SLIGHT MARKS OF THE HANDLE ASSEMBLY PROCESS, WHICH INDICATES THAT THE CAUTERY PIN WAS IN CONTACT WITH THE HANDLE CANNULA BEFORE IT DETACHED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE HANDLE CANNULA DETACHMENT. A DIMENSIONAL INSPECTION WAS PERFORMED AND ALL THE MEASUREMENTS WERE WITHIN MANUFACTURING SPECIFICATIONS. THE COMPLAINT WAS CONFIRMED. THIS FAILURE WAS CAUSED BY IMPROPER ASSEMBLY OF THE HANDLE CANNULA DURING THE MANUFACTURING PROCESS. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT A CAPTIFLEX MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SNARE LOOP WAS POSITIONED AROUND THE TARGET POLYP, THE USER CLOSED THE HANDLE TO CUT THE POLYP. HOWEVER, WHEN THE USER RELEASED THE HANDLE, IT WAS NOTED THAT THE HANDLE CANNULA HAD DETACHED. AS THE POLYP HAD NOT BEEN FULLY CUT THROUGH AND THE SNARE LOOP WAS IN A RETRACTED POSITION, HEMOSTATS WERE USED TO ACTUATE THE HANDLE CANNULA, THUS ALLOWING THE LOOP TO BE REMOVED FROM AROUND THE POLYP. THE DEVICE WAS THEN PULLED OUT THROUGH THE ENDOSCOPE. IT WAS CONFIRMED THAT NOTHING DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CAPTIFLEX MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE SNARE LOOP WAS POSITIONED AROUND THE TARGET POLYP, THE USER CLOSED THE HANDLE TO CUT THE POLYP. HOWEVER, WHEN THE USER RELEASED THE HANDLE, IT WAS NOTED THAT THE HANDLE CANNULA HAD DETACHED. AS THE POLYP HAD NOT BEEN FULLY CUT THROUGH AND THE SNARE LOOP WAS IN A RETRACTED POSITION, HEMOSTATS WERE USED TO ACTUATE THE HANDLE CANNULA, THUS ALLOWING THE LOOP TO BE REMOVED FROM AROUND THE POLYP. THE DEVICE WAS THEN PULLED OUT THROUGH THE ENDOSCOPE. IT WAS CONFIRMED THAT NOTHING DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIFLEX SNARE. THERE WERE NO OTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313014 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562402 15932619

    Patients

    Seq Age Sex Outcome Treatment
    1