BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEMAITRE

    MDR report key: 844881 · Received April 17, 2007

    Report

    Report Number
    844881
    Event Type
    Injury
    Date Received
    April 17, 2007
    Date of Event
    April 2, 2007
    Report Date
    April 17, 2007
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN EXPANDABLE VALVULOTOME WAS USED IN THE PROCEDURE "FEMORAL-POPLITEAL BYPASS," THE VALVULOTOME MADE A 10 CM LONG TEAR IN THE VEIN WHEN THE DOCTOR WAS BRINGING THE VALVULOTOME OUT OF THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEMAITRE CATHETER, VASCULAR MGZ LEMAITRE VASCULAR, INC. * ELV3 1217V

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention