BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR¿

    MDR report key: 2761108 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04038
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE FLARE DETACHED. ADDITIONALLY, THE HANDLE CANNULA WAS SLIGHTLY BENT AND THE SHEATH WAS KINKED IN ITS PROXIMAL SECTION. THE CONDITION IN WHICH THE DEVICE WAS RETURNED RENDERED FUNCTIONAL TESTING IMPOSSIBLE; HOWEVER, THE DEVICE WAS REASSEMBLED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOLLOWING VISUAL EVALUATION. WHEN THE DEVICE HANDLE WAS ACTUATED, THE LOOP EXTENDED FURTHER THAN USUAL, SUGGESTING THE FLARE DETACHMENT OCCURRED DURING MANUFACTURING RATHER THAN DURING USE. IF THE FLARE DETACHED DURING MANUFACTURING, THE SHEATH WOULD BE CUT TO AN INSUFFICIENT LENGTH SUCH THAT THE LOOP, WHEN EXTENDED, WOULD APPEAR TO BE MORE EXTENDED THAN USUAL. THIS IS CONSISTENT WITH THE INVESTIGATION FINDINGS. THE COMPLAINT WAS CONFIRMED; A DETACHED FLARE CAN RESULT IN AN INABILITY TO EXTEND THE SNARE LOOP FROM THE SHEATH. THE CONDITION OF THE RETURNED DEVICE SUGGESTS THE FLARE OPERATION WAS NOT PROPERLY PERFORMED DURING MANUFACTURING. THE KINK IN THE SHEATH AND SLIGHT BEND IN THE HANDLE CANNULA WERE LIKELY CAUSED BY OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MICRO OVAL SNARE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SNARE LOOP WOULD NOT EXTEND INTO THE PATIENT AFTER THE SHEATH EXITED THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPTIVATOR MICRO OVAL SNARE. THE DEVICE WAS INSPECTED AFTER IT WAS REMOVED FROM THE ENDOSCOPE, AND NO VISIBLE DAMAGE WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD" FOLLOWING THE PROCEDURE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION RESULTS: FLARE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIVATOR¿ SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562301 0015208820

    Patients

    Seq Age Sex Outcome Treatment
    1