BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3790831 · Received May 5, 2014

    Report

    Report Number
    3005099803-2014-01851
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF SNARE LOOP FAILED TO CUT. REPORTED EVENT OF HANDLE CANNULA DETACHMENT. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE HANDLE CANNULA BENT AND THE CATHETER KINKED NEAR THE HANDLE. FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE CONDITION OF THE DEVICE. THE COMPLAINT THAT THE HANDLE CANNULA DETACHED AND THE SNARE LOOP FAILED TO CUT WAS NOT CONFIRMED, HOWEVER, THE COMPLAINT OF HANDLE CANNULA BENT WAS CONFIRMED. MOST LIKELY, ANATOMICAL AND PROCEDURAL DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE COULD HAVE CAUSE THE HANDLE CANNULA TO BEND AND THE CATHETER NEAR THE HANDLE TO KINK. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE IDENTIFIED FAILURES IS OPERATIONAL CONTEXT. 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.  A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL SNARE WAS USED IN THE RECTUM DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP FAILED TO CUT THE POLYP AND THE HANDLE CANNULA WAS NOTED TO BE BENT AND DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR MEDIUM OVAL SNARE. 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 THAT A CAPTIVATOR MEDIUM OVAL SNARE WAS USED IN THE RECTUM DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP FAILED TO CUT THE POLYP AND THE HANDLE CANNULA WAS NOTED TO BE BENT AND DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR MEDIUM OVAL SNARE. 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
    267266 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562321 0013337645

    Patients

    Seq Age Sex Outcome Treatment
    1