BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1251279 · Received December 4, 2008

    Report

    Report Number
    3005099803-2008-06928
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A PROCEDURE, THREE RESOLUTION CLIP DEVICES PREMATURELY DEPLOYED INTO THE LARGE INTESTINE. THE PHYSICIAN RETRIEVED THE CLIPS. THE CLIPS DID NOT ENGAGE TISSUE AT ALL. THE PROCEDURE WAS COMPLETED WITH A FOURTH OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS. PATIENT IS "FINE". NOTE: THIS IS THE THIRD REPORT OF THREE RELATED COMPLAINTS. PLEASE REFER TO MFR #S 3005099803-2008-06926, 3005099803-2008-06927.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8070207

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention