BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1193345 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05104
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT WHILE TREATING A GASTRIC BLEED, THREE RESOLUTION CLIP DEVICE CLIPS WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PT COMPLICATIONS. PT IS "STABLE". NOTE: THIS COMPLAINT IS THE SECOND ON THREE DEVICES, PLEASE REFER TO MFR #'S 3005099803-2008-05103, 3005099803-2008-05105 FOR OTHER RELATED REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML6120204

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK