BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA LIQUID EMBOLIC SYSTEM (LES) KIT

    MDR report key: 22948141 · Received September 2, 2025

    Report

    Report Number
    9710358-2025-00010
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 1, 2025
    Report Date
    September 2, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY AND IT WAS CONFIRMED THAT LAVA WAS MIXED ON THE VORTEX MIXER FOR THE FULL 20 MINUTES AS INDICATED ON THE IFU. BLACKSWAN VASCULAR, INC. IS NOT THE MANUFACTURER OF THE VORTEX MIXER BUT DID PROVIDE THE MIXER TO THE CUSTOMER. PROPER MIXING OF THE LAVA DEVICE IS INTEGRAL FOR ITS INTENDED USE. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY SHOULD THE LAVA DEVICE NOT BE PROPERLY MIXED. NOTE, TYPE OF INVESTIGATION CODE 4113 IS APPLICABLE TO THE VORTEX MIXER, WHICH IS NOT MANUFACTURED BY BLACKSWAN VASCULAR, INC. THE CODE DOES NOT APPLY TO THE LAVA LIQUID EMBOLIC SYSTEM KIT.

    Description of Event or Problem · 0

    THE VORTEX MIXER USED IN THE EVENT BECAME EXTREMELY HOT DURING MIXING AND KEPT AUTOMATICALLY SHUTTING OFF (DIGITAL VORTEX GENIE 2 MODEL #SI-A236AMP SERIAL #(B)(6)). PROPER MIXING OF THE LAVA DEVICE IS INTEGRAL FOR ITS INTENDED USE. BLACKSWAN VASCULAR, INC. IS NOT THE MANUFACTURER OF THE VORTEX MIXER BUT DID PROVIDE THE MIXER TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822607 LAVA LIQUID EMBOLIC SYSTEM (LES) KIT Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown