BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 699019 · Received April 12, 2006

    Report

    Report Number
    6000048-2006-00131
    Event Type
    Injury
    Date Received
    April 12, 2006
    Date of Event
    March 20, 2006
    Report Date
    March 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GDO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT A THEREPEUTIC ERCP PROCEDURE WITH PLACEMENT FO A METAL BILIARY STENT. AFTER SUCCESSFUL STENT PLACEMENT, AN AREA CLOSE TO THE PAPPILA WAS DETERMINED TO HAVE A POTENTIAL RISK FOR BLEEDING. A RESOLUTION CLIP DEVICE WAS INSERTED AND DEPLOYED TO THIS AREA. IMMEDIATELY UPON DEPLOYMENT,THE CLIP WAS NOTED TO HAVE OPENED AND DETATCHED FROM THE INTENDED SITE.THE PROCEDURE WAS SUCCESSFULLY COMPLETED UTILIZING A ARGON PLASMA COAGULATION UNIT.THE PATIENT DID NOT SUSTAIN ANY KNOWN COMPLICATIONS AS A RESULT OF THE DEPLOYMENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE HEMOSTASIS GDO BOSTON SCIENTIFIC * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention