BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-34, 2 ML

    MDR report key: 22668151 · Received July 30, 2025

    Report

    Report Number
    3005579300-2025-00005
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    November 1, 2024
    Report Date
    July 30, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, THOUGH THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND WAS NOT USED FOR PATIENT TREATMENT. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE EVENT COULD NOT BE REPLICATED. THE CLUMPING WAS NOTICED UPON RECEIPT. DURING THE INVESTIGATION, THE VIALS WERE MIXED USING VORTEX MIXING PER THE IFU, MIXING WERE FOUND TO BE UNIFORM, AND NO DIFFERENCES WERE OBSERVED BETWEEN VIALS.

    Description of Event or Problem · 0

    ON (B)(6), I ATTENDED A POTENTIAL LAVA CASE. THE PHYSICIAN STATED THEY USED LAVA-34 2ML THE WEEK PRIOR AND THE LAVA DID NOT FUNCTION AS THEY HAD HOPED. THERE WAS A LOT OF PRESSURE AND THE LAVA ACTUALLY CAME BACKWARDS OUT OF THE MICRO AND FLEW AGAINST THE WALL DURING THE CASE. WE DISCUSSED THIS AND THOUGHT IT SEEMED STRANGE. DURING THE CASE ON (B)(6), I BEGAN TO SHAKE 2 6ML VIALS OF LAVA, ONE WAS 18 AND ONE WAS 34, IN CASE THE PHYSICIAN DID DECIDE TO USE THE PRODUCT. I SHOOK FOR AT LEAST 2 CYCLES OF 20 MINUTES AND NOTICED THAT THE VIALS LOOKED VERY DIFFERENT. ONE LOOKED WELL MIXED, AND THE OTHER WAS VERY THIN AND JUST HAD CLUMPS OF THE PRODUCT STICKING TO THE TOP AND BOTTOM OF THE VIAL. I THEN LOOKED AT ALL THE VIALS ON THE SHELF AND NOTICED IT SEEMED TO BE HAPPENING WITH ANOTHER 6 ML VIAL AND POTENTIALLY 2, 2 ML VIALS. ANOTHER STRANGE THING I NOTICED WAS THAT THESE PARTICULAR VIALS HAD A DOT MARKED ON THE TOP OF THE SECURE LID WITH BLACK SHARPIE, ALMOST AS IF THEY WERE MARKED AS SOMETHING WAS WRONG. I THEN BEGAN TO WONDER IF THIS COULD HAVE BEEN THE REASON FOR SOMETHING GOING WRONG IN THE PREVIOUS CASE. DURING THE CASE ON (B)(6), THE PHYSICIAN ACTUALLY DID NOT NEED TO USE LAVA SO THE ISSUE WITH THE VIALS DID NOT IMPACT THE CASE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52265 LAVA-34, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES342 10704 00850055697010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown