BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-34, 2 ML

    MDR report key: 25073699 · Received May 4, 2026

    Report

    Report Number
    9710358-2026-00014
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    March 21, 2026
    Report Date
    May 4, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE POTENTIAL FOR SERIOUS INJURY IF NON-TARGET EMBOLISM OCCURRED DUE TO THE LOSS OF VISUALIZATION OF THE LAVA. THE EVENT DID NOT INVOLVE DEATH OR SERIOUS INJURY. 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. REVIEW OF THE BATCH RECORD SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS. SIRTEX MEDICAL AFFAIRS HAS REVIEWED THE CASE AND HAS STATED THE REPORTED EVENT DESCRIBES REDUCED VISUALIZATION OF LAVA DURING ADMINISTRATION, WITH NO PATIENT HARM AND SUCCESSFUL COMPLETION OF THE PROCEDURE. THERE IS NO EVIDENCE OF CLINICAL IMPACT, AND THIS IS NOT AN ADVERSE EVENT, BUT A DEVICE-RELATED PERFORMANCE ISSUE. THE RELATIONSHIP TO THE DEVICE IS RELATED, AND THE EVENT IS NOT SERIOUS. GIVEN THE POTENTIAL RISK OF NON-TARGET EMBOLIZATION IF VISUALIZATION IS INADEQUATE, THE EVENT IS CONSIDERED REPORTABLE AS A MALFUNCTION AND EXPECTED PER IFU GUIDANCE REQUIRING MAINTAINED VISUALIZATION DURING DELIVERY.

    Description of Event or Problem · 0

    THE PHYSICIAN STATED THEY HAD DIFFICULTY SEEING THE LAVA DURING ADMINISTRATION BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323948 LAVA-34, 2 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES342 0009000221 00850055697027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown