BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRISALUS TRINAV MICROCATHETER

    MDR report key: 20589393 · Received October 31, 2024

    Report

    Report Number
    MW5162066
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 22, 2024
    Report Date
    October 29, 2024
    Manufacturer
    TRISALUS LIFE SCIENCES INC / SUREFIRE MEDICAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRINAV MICROCATHETER MALFUNCTIONED AND CLOGGED, UNABLE TO DELIVER ENTIRE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50328 TRISALUS TRINAV MICROCATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO TRISALUS LIFE SCIENCES INC / SUREFIRE MEDICAL, INC. TNV-21120-35 240326B

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male