BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 6 ML

    MDR report key: 22668020 · Received July 30, 2025

    Report

    Report Number
    3009088444-2025-00001
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    April 30, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A NEW REVIEW OF THIS EVENT WAS PERFORMED. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY. THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY. THE PATIENT WAS TREATED WITH A DIFFERENT DEVICE. 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

    HOSPITAL STAFF FOLLOWED DIRECTIONS BY SHAKING LAVA FOR OVER 20 MINS. THE TECH PULLED UP 2 ONE ML SYRINGES OF LAVA. THE PHYSICIAN SLOWLY INJECTED DMSO THROUGH A NEEDLE, AS HE WAS PERFORMING AN ENDOLEAK PROCEDURE. THE PHYSICIAN THEN INJECTED ONE SYRINGE OF LAVA AND COULD NOT VISUALIZE THE LAVA UNDER FLUOROSCOPY. HE THEN REACHED FOR A SECOND SYRINGE AND SLOWLY INJECTED THE LAVA. HE STOPPED AT ABOUT 0.5 ML SINCE AGAIN HE STILL COULD NOT VISUALIZE THE LAVA. HE FINISHED THE PROCEDURE BY USING A NON SIRTEX/BLACKSWAN PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444806 LAVA-18, 6 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES186 10826 00850055697027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown