BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEMAITRE VALVULOTOME

    MDR report key: 14634502 · Received June 8, 2022

    Report

    Report Number
    1220948-2022-00050
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 7, 2022
    Report Date
    June 8, 2022
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    PMA / PMN Number
    K140042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. WHEN WE ATTEMPTED TO FLUSH THE SHEATH OF THE VALVULOTOME, WE WERE UNABLE TO DO SO DUE TO COAGULATED BLOOD INSIDE THE LUMEN. WHEN WE PULLED THE GREEN HANDLE TO CLOSE THE CENTERING HOOPS/BLADES, WE OBSERVED THAT ONE OF THE BLADES WAS PROTRUDING OUT OF ITS RETAINER SLOT AND DIDN'T SEAT PROPERLY. THE DISTANCE OF THIS RETAINER SLOT WAS MEASURED TO BE WITHIN SPECIFICATION. AT THE CLOSED CONFIGURATION, THE DISTANCE BETWEEN THE SHEATH AND THE RETAINER WAS MEASURED TO BE WITHIN SPECIFICATION. WE 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 LIKELY THE BLADE OR THE CENTERING HOOP WAS DAMAGED DURING THE PROCEDURE INFLUENCED BY THE PATIENT'S ANATOMY/CONDITION. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

    Description of Event or Problem · 0

    DURING VALVULOTOMY, THE SURGEON FELT A RESISTANCE WHEN HE ATTEMPTED TO PUSH THE GREEN HANDLES TO ACTUATE THE BLADES. SO, HE REMOVED THE VALVULOTOME FROM THE PATIENT'S VESSEL. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12463 LEMAITRE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. ELVH1963V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown