BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1200091 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05263
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING THE PROCEDURE TO MARK A TUMOR FOR STENT PLACEMENT A RESOLUTIONS CLIP DEVICE DID NOT DISENGAGE WHEN FIRED. CLIP DID GRASP TISSUE AND PULLED OFF WITHOUT CAUSING DAMAGE TO THE TISSUE. THE CLIP WAS LEFT INSIDE OF THE PATIENT TO BE EVACUATED THROUGH NORMAL BOWEL FUNCTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 OML7092606

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR