BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 24323464 · Received February 12, 2026

    Report

    Report Number
    9710358-2026-00002
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 15, 2026
    Report Date
    May 19, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING AND AN UPDATE WILL BE PROVIDED ON THE NEXT REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER WAS UNABLE TO VISUALIZE THE LAVA UNDER THE FLUOROSCOPE. THE LAVA WAS MIXED USING A VORTEX MIXER FOR 5 MINUTES AND THEN USING THE MIXING KIT FOR 16 PASSES. THE CUSTOMER KNEW THE EMBOLIZATION WORKED AS THEY PUT SOME CONTRAST THROUGH THE BASE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219105 LAVA-18, 2 ML EMBOLIZATION AGENT, VASCULAR QVG SIRTEX MEDICAL, INC. SLLES182 10906 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1