BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRO EXPANDABLE LEMAITRE VALVULOTOME

    MDR report key: 7986426 · Received October 19, 2018

    Report

    Report Number
    1220948-2018-00085
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    September 19, 2018
    Report Date
    October 19, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    UDI-DI
    00840663106653
    PMA / PMN Number
    K140042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION. WE DID NOT EXPERIENCE ANY DIFFICULTY WHILE CLOSING THE HOOPS INTO THE SHEATH. HOWEVER, WE OBSERVED THAT ONE OF THE BLADE WAS STILL PROTRUDING OUT OF THE RETAINER IN A CLOSED CONFIGURATION WHICH COULD HAVE POSSIBLY RESULTED IN THIS INCIDENT. OUR LOT HISTORY RECORDS REVIEW FOR LOT NUMBER ELVH1056V DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER IN THE MANUFACTURING OR PACKAGING PROCESSES. PLEASE NOTE THAT WE DO CONDUCT 100% INSPECTION OF THE BLADE ASSEMBLY DURING THE MANUFACTURING PROCESS. OUR QUALITY GROUP ALSO SAMPLES THESE DEVICES BEFORE FINAL PACKAGING TO ENSURE PROPER BLADE ADJUSTMENT. HOWEVER, IT IS POSSIBLE THAT ONE OF THE BLADES WAS NOT WELL ALIGNED DURING THE MANUFACTURING PROCESS. THE BLADE ALIGNMENT PROCESS INCLUDES MANUAL ADJUSTMENT OF EACH BLADE BY THE OPERATOR. OPERATOR ERRORS, THOUGH RARE, ARE POSSIBLE DUE TO THE MANUAL NATURE OF THE ADJUSTMENTS. WHILE WE ARE INCONCLUSIVE ABOUT THE EXACT ROOT CAUSE OF THIS DEFECT, WE HAVE IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO RESOLVE THIS TYPE OF ISSUE. IN THE CAPA, WE MADE A SERIES OF IMPROVEMENTS AND REPLACEMENTS TO OUR MANUFACTURING FIXTURES TO RESOLVE THIS ISSUE. THIS DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THESE CHANGES. PHYSICIAN HAD TO CUT THE VEIN TO REMOVE THE DEVICE BECAUSE THE DEVICE WAS NOT WORKING PROPERLY WHILE INSIDE THE PATIENT'S VEIN. WE CONTACTED THE HOSPITAL FOR ADDITIONAL INFORMATION. HOWEVER, THE CONTACT PERSON AND THE NURSE WAS UNABLE TO PROVIDE US WITH ANY FURTHER INFORMATION ON WHETHER THE SURGEON SUTURED THE CUT SECTION OF THE VEIN AND WAS STILL ABLE TO USE IT FOR THE BYPASS. THE INCIDENT REPORT FORM THAT WAS RECEIVED FROM THE HOSPITAL STATED THERE WAS NO ANY OTHER IMPACT ON THE PATIENT'S HEALTH. WE ARE STILL INVESTIGATING THE OUTCOME ON THE PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    DURING VALVULOTOMY, AFTER SURGEON INSERTED THE HYDRO LEMAITRE VALVULOTOME INSIDE PATIENT'S VEIN, HE EXPERIENCED DIFFICULTY REMOVING THE DEVICE. SO, HE HAD TO CUT THE VEIN TO REMOVE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824860 HYDRO EXPANDABLE LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELVH1056V 00840663106653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention