BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 23097726 · Received September 19, 2025

    Report

    Report Number
    9710358-2025-00011
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEATH OR SERIOUS INJURY WERE REPORTED DUE TO THE MALFUNCTION AND IT WAS CONFIRMED THAT THE PATIENT OUTCOME WAS SUCCESSFUL USING THE SECOND VIAL OF LAVA. THOUGH THERE WAS NO DEATH OR SERIOUS INJURY IN THIS EVENT, A MDR HAS BEEN FILED DUE TO THE POTENTIAL FOR DEATH OR SERIOUS INJURY DUE TO THE DELAY IN PROCEDURE AND/OR SHOULD THE EVENT OCCUR DURING A MEDICAL PROCEDURE. A REVIEW OF PRODUCTION RECORDS SHOW THE BATCH WAS MANUFACTURED TO APPROVED SPECIFICATION AND MET QUALITY ASSURANCE CRITERIA.

    Description of Event or Problem · 0

    WHILE REMOVING AIR FROM THE SYRINGE FILLED WITH LAVA, THE SYRINGE PLUNGER FELL OUT AND APPROXIMATELY 1 ML OF LAVA WAS LOST ON THE TABLE. THERE WAS NO PATIENT CONTACT AND A PROCEDURAL DELAY OCCURRED WHILE A NEW VIAL OF LAVA/SYRINGE KIT WAS PREPARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764872 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10956 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown