BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANASTOCLIP CLIP APPLIER

    MDR report key: 769457 · Received October 12, 2006

    Report

    Report Number
    MW1040671
    Event Type
    Injury
    Date Received
    October 12, 2006
    Date of Event
    April 26, 2006
    Report Date
    September 20, 2006
    Manufacturer
    *
    Product Code
    GDO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BASILIC VEIN TRANSPOSTION WAS PERFORMED BY DR. HEMOSTASIS WAS ACHEIVED AT PRIMARY PLACEMENT USING PROLENE STAY STUTURE SNA LARGE VCA CLIPS. PT WAS ADMITTED TO ER AT ANOTHER HOSP DUE TO COMPLICATIONS OF THE CASE. THREE TO FOUR CLIPS ON THE FRONT WALL HAD SLIPPED OFF AND THE PT WAS BLEEDING OUT. THE PT WAS SEEN THAT NIGHT BY DR FOR AN EMERGENCY REVISION USING SUTURE FOR ANASTOMOSIS. DR PLACED ABOUT 15 CLIPS ON THE FRONT AND BACK WALL OF THE ANASTOMOSIS. DEVICE WAS NOT RETURNED FOR EVALUATION. LEMAITRE REPRESENTATIVE WENT TO THE HOSP AFTER THE INCIDENT AND SPOKE WITH THE PHYSICIAN. THE PHYSICIAN NOTED THAT HE MAY HAVE MISPLACED THE CLIPS RESULTING IN THE CLIPS COMING OFF. LEMAITRE REP SUGGESTED ATTENDING TRAINING SESSIONS THAT ARE OFFERED BY LEMAITRE VASCULAR, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANASTOCLIP CLIP APPLIER CLIP APPLIER GDO * NA ANC1027

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention