BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3883569 · Received June 19, 2014

    Report

    Report Number
    3005099803-2014-02279
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 28, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THE WIRE KINKED NEAR TO THE PROXIMAL SECTION AND THE HANDLE CANNULA DETACHED. THE HANDLE CANNULA HAD MARKS FROM THE HANDLE ASSEMBLY PROCESS PERFORMED DURING THE MANUFACTURING. ALSO, THE INTERNAL SURFACE OF THE FINGER RING WAS CHECKED AND ONE EDGE OF THE INTERNAL GROOVE IS DAMAGED. FUNCTIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE COMPLAINT WAS CONFIRMED; THE HANDLE CANNULA WAS DETACHED. HOWEVER, REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE FOR THIS EVENT. 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 OF HANDLE CANNULA DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, 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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE HANDLE CANNULA DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SMALL OVAL SNARE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE HANDLE CANNULA DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359781 CAPTIFLEX? SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00562422 0016744770

    Patients

    Seq Age Sex Outcome Treatment
    1