BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 19819760 · Received July 24, 2024

    Report

    Report Number
    1220948-2024-00122
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    June 25, 2024
    Report Date
    July 25, 2024
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    PMA / PMN Number
    K140042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AS IT WAS DISCARDED. THEREFORE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE. THE IFU WARNING STATES: "DO NOT INSERT THE LEMAITRE VALVULOTOME INTO A VESSEL OR EXTRACT FROM A VESSEL IN THE OPEN POSITION. DO NOT ROTATE THE LEMAITRE VALVULOTOME IN A VESSEL. DO NOT ADVANCE THE LEMAITRE VALVULOTOME WITH THE BLADES IN THE OPEN POSITION. FAILURE TO SHEATH THE CUTTING BLADES AND CENTERING HOOPS PRIOR TO RETRACTING THE DEVICE FROM THE VEIN MAY CAUSE DAMAGE AND THE POTENTIAL COMPLICATION WHILE USING THE DEVICE IS VESSEL WALL PERFORATION." THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED. THEREFORE, WE'RE UNABLE TO PERFORM A LOT REVIEW. ALTHOUGH THE ROOT CAUSE COULD NOT BE CONFIRMED, CAPA 2022-025 WAS PREVIOUSLY OPENED TO ADDRESS SIMILAR REPORTS FOR THIS PRODUCT.

    Description of Event or Problem · 0

    THE VALVULOTOME WAS USED DURING AN IN SITU BYPASS OPERATION. THE VEIN WAS SEVERELY INJURED. ACCORDING TO THE STATEMENT, THE VEIN WAS INJURED AND SLIT OPEN. THE VEIN COULD THEN NO LONGER BE USED. ADDITIONAL INFORMATION WAS REQUESTED IN REGARDS TO THE DETAILS OF THE REPORTED INCIDENT, BUT IT WAS NOT SUCCESSFUL. NO OTHER INJURY WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2366664 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other