BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 22667933 · Received July 30, 2025

    Report

    Report Number
    9710358-2025-00004
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    December 18, 2024
    Report Date
    July 30, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 IT WAS STATED THE PATIENT DID FINE. 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

    COULD NOT VISUAL THE LAVA UNDER FLUOROSCOPY. INCIDENT OCCURRED WHEN THE LAVA WAS INJECTED INTO THE TARGET VASCULATURE THAT WAS TO BE EMBOLIZED. THERE WAS A BRANCH THAT SHOWED SOME LAVA ON ANGIO WHERE THE PHYSICIAN DID NOT INTEND IT TO GO. PATIENT WAS FINE AFTER THE PROCEDURE BUT WAS GOING TO BE MONITORED FOR ANY COMPLICATIONS AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49208 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10631 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown