BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1140583 · Received August 28, 2008

    Report

    Report Number
    3005099803-2008-04193
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT RETURNED TO THE FACILITY. THE ROOT CAUSE OF THE FAILURE IS UNDETERMINED.

    Description of Event or Problem · 1

    DURING THE IN-SERVICE (NON-PATIENT SETTING) 5 CLIPS IN A ROW (INCLUDING THE SUBJECT DEVICE) OPENED AND CLOSED FINE. THOUGH AT THE FIRST CLICK OF DEPLOYMENT, THE CLIP OPENED BUT NEVER RECLOSED AND IT POPPED OFF. THE SALES REPRESENTATIVE WAS ABLE TO FINISH THE IN-SERVICE SUCCESSFULLY WITH OTHERS OF THE SAME DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522612 0ML8042801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA