BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1340197 · Received March 5, 2009

    Report

    Report Number
    3005099803-2009-01036
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 3, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE IS NOT BEING RETURNED BY THE HOSPITAL. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IN 2009, BOSTON SCIENTIFIC NEUROMODULATION CORPORATION WAS INFORMED THAT DURING THE PROCEDURE, THE "BLUE PART" OF THE HANDLE DETACHED FROM THE RESOLUTION CLIP DEVICE SHEATH. AS A RESULT, IT WAS VERY DIFFICULT TO ADVANCE THE CLIP OUT OF THE SHEATH. THIS ISSUE OCCURRED WITH A TOTAL OF TWO RESOLUTION CLIP DEVICES USED IN THE PROCEDURE. A THIRD RESOLUTION CLIP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PT COMPLICATIONS. PT IS FINE. NOTE: THIS REPORT IS FOR ONE OF TWO DEVICES USED IN SAME PROCEDURE. PLEASE REFER TO MFR REPORT # 3005099803-2009-01035 FOR THE RELATED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8061810

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK