BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1328214 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-06413
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    September 20, 2006
    Report Date
    September 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN CONTAMINATED AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. BSC REFERENCE: A00037264 / 230975

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2006, THAT A RESOLUTION CLIP DEVICE WAS USED DURING A HEMOSTASIS FOR A BLEEDING ULCER PROCEDURE (MALE PATIENT; ACCORDING TO THE COMPLAINANT, THE "CLIP DID NOT GET OFF THE TEFLON CATHETER". THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND MND BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH M00522610 0ML6040701

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR