BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 22667845 · Received July 30, 2025

    Report

    Report Number
    3005579300-2025-00002
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 24, 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
    IN, 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. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND PASSING QUALITY TEST RESULTS.

    Description of Event or Problem · 0

    TWO VIALS (ONE - 2 ML VIAL OF LAVA-18 AND ONE-2 ML VIAL OF LAVA 34) WERE PLACED ON THE SMALL VORTEX ADAPTER AND THE VORTEX MIXER WAS TURNED ON AT THE APPROPRIATE SPEED. ABOUT 12 MINUTES AFTER THE VIALS WERE PLACED ON THE MIXER, IT MADE A LOUD NOISE AND THE LAVA-18 VIAL CAME OFF OF THE VORTEX. THE STERILE BLUE CAP WAS KNOCKED OFF AND WAS NOT USED AND THE OTHER VIAL WAS FOR ADMINISTRATION. BEFORE PLACING THE VIAL ON THE VORTEX TO COMPLETE THE MIXING, THE UNAFFECTED VIAL WAS TAPED TO THE ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497349 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10618 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown