BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3870865 · Received June 12, 2014

    Report

    Report Number
    3005099803-2014-02210
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 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 DEVICE FOUND THE HANDLE CANNULA DETACHED. A VERY SLIGHT TORQUE MARK FROM OF THE HANDLE CANNULA ASSEMBLY PROCESS WAS FOUND. FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT WAS CONFIRMED; THE HANDLE CANNULA WAS DETACHED, WHICH PREVENTED DEVICE ACTUATION. THERE WAS A VERY SLIGHT TORQUE MARK ON THE HANDLE CANNULA, INDICATING THAT THE HANDLE CANNULA WAS NOT ASSEMBLED PROPERLY. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE IDENTIFIED FAILURE IS MANUFACTURING. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE. 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. 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 THAT A CAPTIVATOR SMALL HEXAGONAL SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP WAS EXTENDED, BUT COULD NOT BE RETRACTED BECAUSE THE WIRE INSIDE THE HANDLE DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPTIVATOR 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR SMALL HEXAGONAL SNARE WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SNARE LOOP WAS EXTENDED, BUT COULD NOT BE RETRACTED BECAUSE THE WIRE INSIDE THE HANDLE DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPTIVATOR 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346978 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562451 16349119

    Patients

    Seq Age Sex Outcome Treatment
    1