BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1133466 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03713
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 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

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR AN EVAL; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED. THE JUNE 2008, 15-MONTH HEMOSTATIC CLIPPING PRODUCT FAMILY TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO EVENTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2008-03714, FOR A DESCRIPTION OF THE OTHER EVENT. A RESOLUTION CLIP DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE IN '08. ACCORDING TO THE COMPLAINANT, WHEN THE DEVICE WAS DEPLOYED, "IT FAILED TO DETACH." NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8030308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK