BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 22907570 · Received August 27, 2025

    Report

    Report Number
    9710358-2025-00009
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 24, 2025
    Report Date
    August 27, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEATH OR SERIOUS INJURY IN THIS EVENT, AND THE POTENTIAL FOR SERIOUS INJURY IS NOT CLEAR. THE IFU PROVIDES INSTRUCTIONS FOR USING THE SYRINGE BUT IT CANNOT BE CONFIRMED THAT THIS EVENT WAS SOLELY RELATED TO USER ERROR. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION, AS A CONSERVATIVE APPROACH, DUE TO A POTENTIAL ISSUE WITH THE DEVICE. A REVIEW OF PRODUCTION RECORDS SHOWS THE BATCH WAS MANUFACTURED TO APPROVED SPECIFICATIONS AND MET ALL QUALITY ASSURANCE CRITERIA.

    Description of Event or Problem · 0

    THE PHYSICIAN STATED HE LIKES THE LAVA PRODUCT BUT WOULD PREFER A DIFFERENT SYRINGE TO DELIVER THE PRODUCT. THE PHYSICIAN STATED THAT THE RUBBER FLANGE ON STOPPER OF SYRINGE STICKS WHEN TRYING TO ADMINISTER LAVA AND CAUSES A SMALL JUMP OF PLUNGER WHEN TRYING TO DELIVER PRODUCT. IT IS NOT AS SMOOTH AS OTHER PRODUCTS AND THE PHYSICIAN WORRIES ABOUT HIS CONTROL WITH THE LAVA SYRINGE AS THE STICKING OF PLUNGER CAUSES A JUMP ON SYRINGE WHEN TRYING TO DELIVER THE LAVA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498506 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10853 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown