BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 MM OVER-THE-WIRE LEMAITRE VALVULOTOME

    MDR report key: 7975612 · Received October 17, 2018

    Report

    Report Number
    1220948-2018-00084
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 17, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663100132
    PMA / PMN Number
    K132190
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION SINCE THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. OUR LOT HISTORY RECORDS REVIEW FOR THIS LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER IN THE MANUFACTURING OR THE PACKAGING PROCESSES. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. THEREFORE, WE BELIEVE THAT IT WAS AN ISOLATED INCIDENT. PLEASE NOTE THAT WE DO CONDUCT 100% INSPECTION OF THE BLADE ASSEMBLY DURING THE MANUFACTURING PROCESS. OUR QUALITY CONTROL ALSO SAMPLES THESE DEVICES BEFORE FINAL PACKAGING TO ENSURE PROPER BLADE ADJUSTMENT. IT IS POSSIBLE THE BLADE OR THE CENTERING HOOP WAS DAMAGED DURING THE PROCEDURE INFLUENCED BY PATIENT'S ANATOMY/CONDITION OR THE OPERATOR'S MANIPULATION OF THE DEVICE DURING USE SINCE THE DEVICE WAS FOUND TO BE OPERATIONAL DURING PREUSE CHECK. OUR IFU PROPERLY WARNS USERS NOT TO ROTATE THE DEVICE IN A VESSEL AND NOT TO ADVANCE THE CENTERING HOOPS IN AN OPEN CONFIGURATION AS IT MAY CAUSE INJURY TO THE VEIN. SURGEON SUTURED THE CUT SECTION OF THE VEIN USING 6.0 PROLENE. SALES REP. ON (B)(6) 2018 STATED THAT THE PATIENT WAS DOING FINE IN REGARDS TO THE BYPASS.

    Description of Event or Problem · 1

    DURING FEMORAL POSTERIOR TIBIAL IN-SITU BYPASS, THE CUTTING BLADES OF THE VALVULOTOME CUT THE GREAT SAPHENOUS VEIN ABOUT 4-5 CM ABOVE THE DISTAL END. 6.0 PROLENE WAS USED TO SUTURE THE CUT SECTION OF THE VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815482 2.0 MM OVER-THE-WIRE LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELV61045V 00840663100132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention