BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 22667860 · Received July 30, 2025

    Report

    Report Number
    3005579300-2025-00003
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    September 13, 2024
    Report Date
    July 30, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A NEW REVIEW OF THIS EVENT WAS PERFORMED. A RETROSPECTIVE MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS.

    Description of Event or Problem · 0

    CUSTOMER WAS ONLY ABLE TO GET 1.2 ML OUT OF THE 2ML-18 VIAL DURING CASE. PHYSICIAN WAS UPSET AND UNABLE TO USE LAVA ON ADDITIONAL VESSEL AND STATED THE PATIENT MIGHT HAVE TO COME BACK IN AND GET RE-TREATED WITH LAVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514078 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10618 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown