BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1213853 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05442
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORP WAS INFORMED THAT DURING A PROCEDURE, TWO RESOLUTION CLIP DEVICES PREMATURELY DEPLOYED. PROCEDURE SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PT COMPLICATIONS. NOTE: THIS MFR REPORT PERTAINS TO THE FIRST OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. MFR # 3005099803-2008-05443 PERTAINS TO THE SECOND EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8052807

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK