BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-34, 2 ML

    MDR report key: 22668028 · Received July 30, 2025

    Report

    Report Number
    9710358-2025-00005
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    June 5, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697010
    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. THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY AND IT WAS CONFIRMED THAT THE PHYSICIAN STATED THE PATIENT'S VESSEL SEEMED OCCLUDED. THE DEVICE LABELING (IFU) STATES ADEQUATE FLUOROSCOPIC VISUALIZATION MUST BE MAINTAINED DURING LAVA DELIVERY AND TO STOP LAVA DELIVERY IF VISUALIZATION IS LOST UNTIL ADEQUATE VISUALIZATION IS REESTABLISHED. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS.

    Description of Event or Problem · 0

    LAVA WAS NOT VISIBLE UNDER FLUORO. VIAL WAS ON THE VORTEX FOR 8 MINS THEN HAND MIXED WITH THE MIXING KIT FOR 30 PASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445724 LAVA-34, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES342 10938 00850055697010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown