BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHEVALIER VALVULOTOME

    MDR report key: 17319446 · Received July 13, 2023

    Report

    Report Number
    1220948-2023-00125
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 13, 2023
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663110476
    PMA / PMN Number
    K140042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED PROBLEM WAS CONFIRMED WITH THE PROVIDED PHOTO. IT SHOWS TWO BURRS/UNINTENDED FLASH ON THE CUTTER (PLASTIC). THE LOT HISTORY RECORD FOR THE DEVICE WAS REVIEWED, NO ISSUES WERE FOUND DURING MANUFACTURING OR PACKAGING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. CAPA 2023-022 BEING INITIATED AS WELL AS A CLASS II RECALL BEING INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CHEVALIER VALVULOTOME TORE THE HARVESTED VEIN. THE 2 ERGOTS ON THE TIP MAY LIKELY BE THE CAUSE OF THE ISSUE. THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE SURGEON HAD TO REPAIR THE VEIN. THE NURSE INSPECTED THE REST OF THE PRODUCTS ON THE SHELF AND THEY ALL SEEM TO HAVE IDENTICAL TIPS AS SHOWN IN THE ATTACHED IMAGE. ALL UNITS ON THE SHELF HAVE BEEN QUARANTINED WAITING FOR CONFIRMATION FROM LEMAITRE VASCULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312096 CHEVALIER VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. CHV1004 00840663110476

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H| O