BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 23757203 · Received December 9, 2025

    Report

    Report Number
    9710358-2025-00017
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 9, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEATH OR SERIOUS INJURY WERE REPORTED DUE TO THE MALFUNCTION AS THE DEVICE WAS NOT USED ON A PATIENT. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION, DUE TO THE POTENTIAL FOR DEATH OR SERIOUS INJURY IF THE LOSS OF VISUALIZATION OF THE LAVA WERE TO OCCUR DURING A PROCEDURE CAUSING NON-TARGET EMBOLISM. A BATCH RECORD REVIEW WAS PERFORMED AND NO DEVIATIONS OR ISSUES ASSOCIATED WITH THE LOT WERE FOUND. ADDITIONALLY, THE RECORDED MASS-PER-VIAL DATA WERE REVIEWED, AND ALL VIALS WERE DOCUMENTED AS BEING WITHIN THE ESTABLISHED SPECIFICATIONS. NO DISCREPANCIES WERE IDENTIFIED THAT WOULD INDICATE A MANUFACTURING DEFICIENCY OR CONCERN WITH TANTALUM CONTENT. SIRTEX HAS MADE MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE FOR FURTHER INVESTIGATION, BUT THE DEVICE HAS NOT BEEN RETURNED. SHOULD THE DEVICE BE RECEIVED BY SIRTEX, A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION.

    Description of Event or Problem · 0

    THE PHYSICIAN NOTIFIED SIRTEX MEDICAL THAT ONE OF THE LAVA VIALS THEY HAD IN STOCK SEEMED VERY DILUTED AND APPEARED TO HAVE LITTLE TO NO TANTALUM IN IT. THE DEVICE WAS NOT USED ON THE PATIENT BUT THE PHYSICIAN MIXED THE DEVICE ON THE VORTEX MIXER FOR 20 MINUTES AND NOTED THE VIAL APPEARED "WATERED DOWN" AS THEY PREPARED TO ASPIRATE. ADDITIONALLY, THE PHYSICIAN PERFORMED THE MIXING USING THE MIXING KIT. THE PHYSICIAN PLACED THE DEVICE UNDER FLUOROSCOPY AND NOTED THAT IT WAS NOT RADIOPAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2772676 LAVA-18, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES182 10873 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown