BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1231126 · Received November 12, 2008

    Report

    Report Number
    3005099803-2008-06266
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Report Date
    October 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    EVENT DATE IS UNK. IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT PRIOR TO A PROCEDURE, THE PHYSICIAN NOTED THAT THE RESOLUTION CLIP DEVICE OVER-SHEAT WAS DAMAGED AND "STRUCK" TO THE CLIP. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PATIENT COMPLICATIONS. PATIENT IS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML8052008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK