BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 24468687 · Received February 27, 2026

    Report

    Report Number
    1220948-2026-00034
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 27, 2026
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663106653
    PMA / PMN Number
    K140042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION AS IT WAS DISCARDED AT THE SITE; THEREFORE, THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PREVIOUS INVESTIGATIONS INTO THIS ISSUE HAVE FOUND THE FAILURE WAS LIKELY DUE TO A 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. 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 UPON OPENING THE PACKAGE, THE SHEATH DID NOT FULLY RETRACT, LEAVING THE BLADE EXPOSED. THE DEVICE WAS NOT USED ON A PATIENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534536 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELVH00002883 00840663106653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown