BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 17664584 · Received August 31, 2023

    Report

    Report Number
    1220948-2023-00140
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 31, 2023
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663106653
    PMA / PMN Number
    K140042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND CONFIRMED THE REPORTED INCIDENT. WHEN THE GREEN HANDLE WAS PULLED TO CLOSE THE BLADES INTO ITS RETAINER SLOT ONE OF THE BLADES WAS PROTRUDING OUT OF THE RETAINER SLOT AND DIDN'T SIT PROPERLY ON THE SLOT. NO DAMAGE TO THE BLADE WAS FOUND. 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. THE BLADE PROCESS INCLUDES MANUAL MANIPULATION OF EACH BLADE BY THE OPERATOR. OPERATOR ERRORS ARE POSSIBLE DUE TO THE MANUAL NATURE OF THE ADJUSTMENTS. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. CAPA 2022-025 WAS OPENED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE LEMAITRE VALVULOTOME DID NOT SHEATH PROPERLY AFTER FIRST PASS DURING INSITU BYPASS- FEM-TIB PROCEDURE. A NEW VALVULOTOME WAS OPENED AND USED FOR THE 2ND PASS. NO INJURY WAS REPORTED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125006 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELVH2239V 00840663106653

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown