BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 6 ML

    MDR report key: 22667976 · Received July 30, 2025

    Report

    Report Number
    3005579300-2025-00006
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    January 28, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A NEW REVIEW OF THIS EVENT WAS PERFORMED. A RETROSPECTIVE MDR HAS BEEN FILED DUE TO THE POTENTIAL FOR SERIOUS INJURY OUT OF AN ABUNDANCE OF CAUTION. THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY AND THE PATIENT WAS TREATED WITH ANOTHER LAVA DEVICE THAT WAS ON HAND. THE DEVICE LABELING (IFU) STATES ADEQUATE FLUOROSCOPIC VISUALIZATION MUST BE MAINTAINED DURING LAVA DELIVERY AND TO STOP LAVA DELIVERY IF VISUALIZATION IS LOST UNTIL ADEQUATE VISUALIZATION IS REESTABLISHED. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS.

    Description of Event or Problem · 0

    WHILE INJECTING FIRST TWO SYRINGES OF LAVA, IT WAS NOT SEEN ON FLUORO. THE PHYSICIAN PUT THE SYRINGES UNDER FLUORO AND THEY WERE NOT RADIOPAQUE. ANOTHER VIAL WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55031 LAVA-18, 6 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES186 10826 00850055697027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown