BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-34, 2 ML

    MDR report key: 23229888 · Received October 6, 2025

    Report

    Report Number
    9710358-2025-00013
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 6, 2025
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS STATED THAT THERE WAS NO DEATH OR SERIOUS INJURY DUE TO THE MALFUNCTIONS DESCRIBED IN THE PHYSICIAN FEEDBACK ON THE DEVICE SYRINGE. THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION, DUE TO A POTENTIAL ISSUE WITH THE DEVICE WHICH COULD CAUSE A DELAY IN PROCEDURE AND/OR SHOULD THE EVENT OCCUR DURING A MEDICAL PROCEDURE.

    Description of Event or Problem · 0

    PHYSICIANS PROVIDED FEEDBACK STATING THEY LIKED THE "WINGS" ON THE LAVA SYRINGES BUT EXPERIENCED THE FOLLOWING PROBLEMS: THE PLUNGER DISCONNECTS FROM THE RUBBER STOPPER, THE SYRINGE STICKS INITIALLY ON FIRST PUSH OF DELIVERY OF PRODUCT, AND THE PLUNGER COMES OUT OF THE CYLINDER IF THEY DRAW UP TOO MUCH PRODUCT. THE PHYSICIANS STATED THERE WAS NO PATIENT ISSUES BUT THIS WAS PROVIDED AS A GENERAL COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478446 LAVA-34, 2 ML Embolization Agent, Vascular QVG BLACKSWAN VASCULAR, INC. SLLES342

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown