BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU-INCISE VALVULOTOME

    MDR report key: 9644599 · Received January 29, 2020

    Report

    Report Number
    1220948-2020-00013
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Report Date
    January 29, 2020
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    MGZ
    PMA / PMN Number
    K930011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE FAILURE. THIS VALVULOTOME WAS MANUFACTURED BY URESIL, LLC. WE ACQUIRED THIS PRODUCT LINE FROM URESIL, LLC. ON JULY 2019. WE COULD NOT DETERMINE IF THE MALFUNCTION WAS DETECTED DURING PRE-USE OR DURING USAGE OF THE DEVICE. WE HAVE REACHED OUT TO THE CUSTOMER FOR CLARIFICATION. HOWEVER, WE DID NOT RECEIVE ANY RESPONSE FROM THE CUSTOMER REGARDING THIS INCIDENT. AT THIS TIME, WE REMAIN INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE FAILURE AS WELL AS THE EXACT FAILURE THAT OCCURRED WITH THIS DEVICE.

    Description of Event or Problem · 1

    THE CONNECTOR OF THE TRU-INCISE VALVULOTOME SEPARATED FROM ITS MAIN UNIT. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108500 TRU-INCISE VALVULOTOME VALVULOTOME MGZ LEMAITRE VASCULAR, INC. 8E398

    Patients

    Seq Age Sex Outcome Treatment
    1