BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 23457450 · Received November 3, 2025

    Report

    Report Number
    9710358-2025-00015
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 3, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEATH OR SERIOUS INJURY WERE REPORTED DUE TO THE MALFUNCTION AND AN ADDITIONAL VIAL OF LAVA WAS USED TO TREAT THE PATIENT. SIRTEX LEARNED THAT THE CUSTOMER ATTEMPTED TO INVERT THE VIAL SO THE LAVA WOULD DRAIN DOWN THE SIDE OF THE VIAL TO POOL AT THE TOP TO DRAW OUT ALL THE PRODUCT. THOUGH THERE WAS NO DEATH OR SERIOUS INJURY IN THIS EVENT, A MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION, DUE TO THE POTENTIAL FOR DEATH OR SERIOUS INJURY OF UNCONTROLLED HEMORRHAGE IF THE MALFUNCTION CAUSED THE PATIENT TO NOT BE TREATED OR FOR THE DELAY IN PROCEDURE. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS. SIRTEX HAS CONFIRMED THAT THE DEVICE WILL NOT BE RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER WAS ONLY ABLE TO DRAW 1.6 ML OF THE LAVA-18, 2 ML VIAL. AN ADDITIONAL LAVA VIAL WAS NEEDED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481239 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10878 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown