BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 23838629 · Received December 18, 2025

    Report

    Report Number
    1220948-2025-00221
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 28, 2025
    Report Date
    December 18, 2025
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663111169
    PMA / PMN Number
    K140042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE PHOTO PROVIDED CONFIRMED THE REPORT. PREVIOUS INVESTIGATIONS INTO THIS ISSUE HAVE FOUND THE FAILURE WAS DETERMINED TO BE CENTERING HOOP TO WIRE WELDING ERROR ALONG WITH OPERATOR ADJUSTMENT ERROR. DURING THE WELDING PROCESS, THIS CENTERING HOOP WAS LIKELY NOT PROPERLY ALIGNED AGAINST ITS RETAINER SLOT. CAPA 2022-025 WAS PREVIOUSLY IMPLEMENTED TO ADDRESS THIS ISSUE, AND NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE DEVICE INVOLVED WAS MANUFACTURED AFTER THE CAPA WAS IMPLEMENTED. ALTHOUGH THE ISSUE OCCURRED POST-IMPLEMENTATION, THE OVERALL OCCURRENCE OF THIS ISSUE HAS DECREASED SINCE THE CAPA WAS PUT IN PLACE. THE PRODUCTION AND TRACEABILITY RECORD FOR THE DEVICE WAS REVIEWED; NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. ALL QUALITY CONTROL TESTS WERE COMPLETED SUCCESSFULLY AND MET SPECIFICATION. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE BLADES COULD NO LONGER BE FULLY RETRACTED. THE PATIENT IS DOING WELL WITH NO REPORTED INJURIES. THE DEVICE HAD BEEN PRE-CHECKED PRIOR TO USE. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242529 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELVH00002755 00840663111169

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown