BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 17309177 · Received July 12, 2023

    Report

    Report Number
    1220948-2023-00111
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    June 8, 2023
    Report Date
    July 12, 2023
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663106653
    PMA / PMN Number
    K140042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WE HAVE 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 SEAT PROPERLY ON THE SLOT. NO DAMAGE TO THE BLADE WAS FOUND. WE OBSERVED THAT THE BLADES WERE INCLINED OUTWARDS, PREVENTING THEM FROM PROPERLY INSERTING INTO ITS RETAINER SLOT. CAPA 2022-025 WAS PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED LEMAITRE VALVULOTOME HAD RESISTANCE WHEN INSERTED AND READY TO DEPLOY DURING FEM-TIB BYPASS PROCEDURE RESULTING IN TEAR OF VEIN. THE SURGERY WAS PROLONGED FOR 5 HOURS AND PATIENT HAD EXTENDED STAY IN HOSPITAL. A SECOND VALVULOTOME WAS USED TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239950 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. 1009-00 ELVH1995V 00840663106653

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H