BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1202359 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05326
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A PROCEDURE, THE RESOLUTION CLIP DEVICE CLIP DID NOT FULLY OPEN. ANOTHER OF A SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT COMPLICATIONS. PATIENT IS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8052004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK