BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 24711949 · Received March 30, 2026

    Report

    Report Number
    1220948-2026-00056
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 15, 2026
    Report Date
    March 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
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. 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 LEMAITRE VALVULOTOME HAD BEEN USED TWICE, AND UPON REMOVAL FROM THE BODY, IT WAS OBSERVED THAT THE BLADE WOULD NOT RETRACT INTO THE SHEATH. NO ADDITIONAL COMPLICATIONS OR PATIENT INJURY WERE REPORTED. IT IS UNKNOWN IF THE DEVICE WAS CHECKED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779385 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELVH00002748 00840663106653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown