BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 23223929 · Received October 6, 2025

    Report

    Report Number
    9710358-2025-00012
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 6, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEATH OR SERIOUS INJURY WERE REPORTED DUE TO THE MALFUNCTION AND IT WAS CONFIRMED THAT ONCE THE NEW CATHETER AND VIAL OF LAVA WERE REPLACED, THE PRODUCT WAS DEPLOYED TO THE PATIENT SUCCESSFULLY. TRUSELECT IS NOT A CATHETER VALIDATED WITH THE DEVICE AS INDICATED ON THE LABELING, HOWEVER IT IS STATED THAT THE CATHETER IS DMSO COMPATIBLE BY ITS MANUFACTURER. 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 DEVICE TO NOT BE DELIVERED OR FOR THE DELAY IN PROCEDURE. A REVIEW OF PRODUCTION RECORDS SHOW THE BATCHES WERE MANUFACTURED TO APPROVED SPECIFICATIONS AND MET QUALITY ASSURANCE CRITERIA.

    Description of Event or Problem · 0

    THE PHYSICIAN HAD A PATIENT WITH A GI BLEED. LAVA POLYMERIZED IN HUB OF CATHETER AND THE PRODUCT WAS NOT DEPLOYED. THE CATHETER WAS REMOVED AND A NEW TRUSELECT CATHETER AND A NEW VIAL OF LAVA WERE UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478078 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10944, 10956

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown