BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1070394 · Received July 3, 2008

    Report

    Report Number
    3005099803-2008-01076
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE MAY 2008 15- MONTH HEMOSTATIC CLIPPING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A RESOLUTION CLIP DEVICE WAS USED DURING A HEMOSTASIS PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, FOLLOWING A POLYPECTOMY PROCEDURE, IN THE COLON, A RESOLUTION CLIP DEVICE WAS ADVANCED THROUGH A COLONOSCOPE. ONCE THE CLIP EXITED THE SCOPE, INSIDE THE PATIENT, THE OUTER SHEATH WAS PULLED BACK TO EXPOSE THE CLIP. IT WAS THEN NOTED THAT "THE CLIP WAS NOT PROPERLY ATTACHED TO THE DELIVERY SYSTEM BUT HANGING ON ONLY BY THE INNER CONNECTING PIN." REPORTEDLY, THE CLIP WAS WITHDRAWN AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH A SECOND RESOLUTION CLIP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS ISSUE, AND THE PT WAS REPORTED AS "STABLE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML6050302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK