BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP

    MDR report key: 1161482 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04580
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008, THAT A RESOLUTION CLIP DEVICE WAS USED DURING A HEMOSTASIS PROCEDURE PERFORMED THREE DAYS PRIOR. ACCORDING TO THE COMPLAINANT, WHILE USING THE DEVICE, THE BLUE HANDLE SEPARATED FROM THE PROTECTIVE SLEEVE; THE SLEEVE COULD NOT BE SLID BACK FROM THE CLIP IN ORDER TO POSITION THE CLIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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 "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP MND BOSTON SCIENTIFIC CORPORATION M00522611 OML8041605

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK