BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-34, 2 ML

    MDR report key: 25074213 · Received May 4, 2026

    Report

    Report Number
    9710358-2026-00015
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 8, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. REVIEW OF THE BATCH RECORD SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS. SIRTEX MEDICAL AFFAIRS HAS REVIEW THE CASE AND HAS STATED THE REPORTED EVENT REPRESENTS A DEVICE MALFUNCTION (SYRINGE PLUNGER DISENGAGEMENT LEADING TO PRODUCT LEAKAGE) WITH NO PATIENT HARM AND SUCCESSFUL PROCEDURE COMPLETION. THERE IS NO EVIDENCE OF CLINICAL IMPACT, AND THUS THIS IS NOT AN ADVERSE EVENT, BUT A DEVICE-RELATED PRODUCT QUALITY ISSUE. THE RELATIONSHIP TO THE DEVICE IS RELATED, AND THE EVENT IS NOT SERIOUS FROM A PATIENT SAFETY PERSPECTIVE. GIVEN THE POTENTIAL FOR PROCEDURAL DISRUPTION IF OCCURRING DURING ADMINISTRATION, THE EVENT IS CONSIDERED REPORTABLE AS A MALFUNCTION.

    Description of Event or Problem · 0

    THE COMPLAINT STATED THE SYRINGE PLUNGER COMES ALL THE WAY OUT OF THE SYRINGE AND HAS CAUSED LAVA TO SPILL OUT MULTIPLE TIMES. THERE WAS NO PATIENT HARM AND PROCEDURE WAS COMPLETED. IT WAS SUGGESTED TO HAVE BETTER SYRINGES AND TO HAVE DIFFERENT COLOR LABELS FOR LAVA-18 AND LAVA-34 AS CURRENTLY BOTH ARE ORANGE AND ARE HARD TO DIFFERENTIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629492 LAVA-34, 2 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES342 0009000221 00850055697027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown