BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR?

    MDR report key: 3311247 · Received August 27, 2013

    Report

    Report Number
    3005099803-2013-09726
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Report Date
    August 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE HANDLE CANNULA TO BE SLIGHTLY BENT AND DETACHED. THE CATHETER PRESENTED KINKS NEAR THE HANDLE AS WELL. THE HANDLE CANNULA PRESENTED SLIGHT MARKS OF THE HANDLE ASSEMBLY PROCESS, WHICH INDICATES THAT THE CAUTERY PIN WAS IN CONTACT WITH THE HANDLE CANNULA BEFORE IT DETACHED. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE HANDLE CANNULA DETACHMENT. A DIMENSIONAL INSPECTION WAS PERFORMED AND ALL THE MEASUREMENTS WERE WITHIN MANUFACTURING SPECIFICATIONS. THE COMPLAINT WAS CONFIRMED. THIS FAILURE WAS CAUSED BY IMPROPER ASSEMBLY OF THE HANDLE CANNULA DURING THE MANUFACTURING PROCESS. THERE IS AN INVESTIGATION IN PLACE TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    EXACT PATIENT AGE IS UNKNOWN BUT IS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND DEVICE MANUFACTURED DATES ARE UNKNOWN. HOWEVER, IT WAS CONFIRMED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. (B)(4). THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, 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 CAPTIVATOR MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE HANDLE CANNULA DETACHED DURING THE PROCEDURE. 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 WAS REPORTED TO BE "FINE" FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIVATOR MEDIUM OVAL SNARE WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, THE HANDLE CANNULA DETACHED DURING THE PROCEDURE. 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 WAS REPORTED TO BE "FINE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418757 CAPTIVATOR? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562321

    Patients

    Seq Age Sex Outcome Treatment
    1