BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 6 ML

    MDR report key: 24445539 · Received February 25, 2026

    Report

    Report Number
    9710358-2026-00004
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 25, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING FILED FOR THE POTENTIAL OF SERIOUS INJURY AS THIS WAS AN EMERGENT CASE. THERE WAS NO REPORTED DEATH OR SERIOUS INJURY TO THE PATIENT. A DIFFERENT DEVICE WAS USED TO COMPLETE THE CASE. SIRTEX ENGINEERING HAS STATED THE DESIGN VERIFICATION TESTING OF THE LAVA LES WAS PERFORMED ON LAVA VIALS THAT WERE SUBJECTED TO ENVIRONMENTAL CONDITIONING AND DISTRIBUTION TESTING PER ASTM F2825 AND ASTM AND MET ALL PERFORMANCE AND FUNCTIONAL REQUIREMENTS. DMSO, THE MAIN CONSTITUENT OF THE LIQUID EMBOLIC SOLUTION, HAS THE PHYSICAL PROPERTY OF FREEZING AT ABOUT 18.55DC (65.4DF). THE PRODUCT IS SHIPPED WITH 2-INCHES THICK INSULATION PLUS 3 PACKS OF 24 OZ GEL REFRIGERANT (GEL PACKS) PER INTERNAL SHIPPING PROCEDURES. STORAGE INSTRUCTIONS IN THE LAVA LES IFU STATE TO THAW THE PRODUCT AT ROOM TEMPERATURE IF IT SOLIDIFIES. A BATCH RECORD REVIEW WAS PERFORMED AND SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS WITH PASSING QUALITY TEST RESULTS AND WITH NO NONCONFORMITIES OR DEVIATIONS.

    Description of Event or Problem · 0

    THE FACILITY PICKED UP THE LAVA UNIT FROM THE LOADING DOCK AT 1230PM ON (B)(6) 2026 AND IMMEDIATELY TOOK IT TO THE PHYSICIAN WHO NEEDED IT FOR A CASE. WHEN THE IR TECHS TRIED TO INJECT LAVA OUT OF THE VIAL, THEY NOTICED IT WAS FROZEN. THEY PROCEEDED TO NOT USE LAVA AND USE ANOTHER DEVICE TO COMPLETE THE CASE. LAVA WAS OPENED BUT NOT USED DUE TO IT BEING FROZEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371926 LAVA-18, 6 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown