BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1171420 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04638
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN IMPLANTED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A RESOLUTION CLIP DEVICE WAS USED DURING A PROCEDURE TO REPAIR A BLEEDING ULCER PERFORMED THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, DIFFICULTY WAS EXPERIENCED DEPLOYING THE CLIP. THE CLIP DID NOT CAUSE ANY TISSUE TRAUMA ONCE IT WAS DEPLOYED. THE PROCEDURE COMPLETED WITH THE SAME RESOLUTION CLIP DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML7071106

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR