BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1230355 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06150
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 CANNOT BE DETERMINED. .

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A PROCEDURE, THE FIRST RESOLUTION CLIP DEVICE WAS DEPLOYED AND PLACED SUCCESSFULLY. THE SECOND AND THIRD CLIPS CLOSED ON TISSUE, BUT WOULD NOT RELEASE. THE PHYSICIAN WAS ABLE TO "WIGGLE" THE HANDLE AND OPEN AND CLOSE TO GET THE CLIP TO RELEASE WITHOUT TEARING ANY TISSUE. THE PHYSICIAN COMPLETED THE PROCEDURE BY INJECTING EPINEPHRINE WITH NO PT COMPLICATIONS. PT IS "FINE". NOTE: THIS COMPLAINT IS THE FIRST OF TWO DEVICES USED IN THE PROCEDURE. REFER TO MFR'S 3005099803-2008-06151 FOR OTHER RELATED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML6090502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK