BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-34, 2 ML

    MDR report key: 24802619 · Received April 7, 2026

    Report

    Report Number
    9710358-2026-00011
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 7, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY AND IT WAS CONFIRMED THAT THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE WITH ANOTHER VIAL THAT DID NOT BREAK. (B)(6), INC. IS NOT THE MANUFACTURER OF THE VORTEX MIXER. 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. (B)(6) AFFAIRS HAS STATED THE OVERALL BENEFIT-RISK PROFILE OF THE LAVA SYSTEM REMAINS UNCHANGED, AND THIS EVENT DOES NOT ALTER THE SAFETY PROFILE OF THE DEVICE.

    Description of Event or Problem · 0

    THE VORTEX MIXER AND ATTACHMENT USED IN THIS EVENT DID NOT SECURELY HOLD THE VIAL OF LAVA CAUSING IT TO COME OFF THE MIXER AND BREAK. PROPER MIXING OF THE LAVA DEVICE IS INTEGRAL FOR ITS INTENDED USE. SIRTEX MEDICAL, INC. IS NOT THE MANUFACTURER OF THE VORTEX MIXER OR THE ATTACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265103 LAVA-34, 2 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES342 10959 00850055697010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown