BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIFLEX?

    MDR report key: 3790531 · Received May 5, 2014

    Report

    Report Number
    3005099803-2014-01871
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 11, 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

    THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. REPORTED EVENT: HANDLE CANNULA DETACHED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE IS RECEIVED, UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, A SUPPLEMENTAL MEDWATCH WILL BE FILED IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPTIFLEX SNARE WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE HANDLE CANNULA OF THE SNARE WAS NOTED TO BE DETACHED FROM THE FINGER RINGS, AND THE DEVICE COULD NOT BE RETRACTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS CONFIRMED THAT THERE WERE NO ADVERSE PATIENT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269216 CAPTIFLEX? POLYPECTOMY SNARE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK58

    Patients

    Seq Age Sex Outcome Treatment
    1