BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3944602 · Received July 18, 2014

    Report

    Report Number
    3005099803-2014-02487
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    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

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED PRODUCT FOUND THE HANDLE CANNULA DETACHED. THE HANDLE CANNULA PRESENTED MARKS FROM THE HANDLE ASSEMBLY PROCESS. THE HANDLE WAS DISASSEMBLED AND THE INTERNAL SURFACE OF THE FINGER RING ASSEMBLY WAS INSPECTED. ONE EDGE OF THE INTERNAL GROOVE WAS FOUND TO BE DAMAGED. FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE COMPLAINT WAS CONFIRMED, THE HANDLE CANNULA DETACHED WHICH MADE THE DEVICE INOPERABLE. THIS WAS CAUSED BY A DIMENSIONAL ISSUE OF THE FINGER RING COMPONENT WHICH IS RELATED TO THE COMPONENT MOLDING. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS DESIGN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: HANDLE CANNULA DETACHED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED TO REMOVE ONE POLYP SUCCESSFULLY. HOWEVER, WHEN THE USER ATTEMPTED TO CUT A SECOND POLYP, THE SNARE LOOP WOULD NOT CLOSE ALL THE WAY. IT WAS NOTICED THAT THE HANDLE CANNULA HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED DURING A COLONOSCOPY WITH POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS USED TO REMOVE ONE POLYP SUCCESSFULLY. HOWEVER, WHEN THE USER ATTEMPTED TO CUT A SECOND POLYP, THE SNARE LOOP WOULD NOT CLOSE ALL THE WAY. IT WAS NOTICED THAT THE HANDLE CANNULA HAD DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422513 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562422 0016781121

    Patients

    Seq Age Sex Outcome Treatment
    1