BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3173384 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05009
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF HANDLE CANNULA DETACHED. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CAPTIVATOR LARGE OVAL SNARE WAS USED DURING A POLYPECTOMY PROCEDURE IN THE COLON ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE CANNULA DETACHED FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274063 CAPTIVATOR? LARGE OVAL ? MEDIUM STIFF FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00561311 15792637

    Patients

    Seq Age Sex Outcome Treatment
    1