BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 2 ML

    MDR report key: 24561313 · Received March 10, 2026

    Report

    Report Number
    9710358-2026-00006
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 10, 2026
    Manufacturer
    SIRTEX MEDICAL, INC.
    Product Code
    QVG
    UDI-DI
    00850055697003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEATH OR SERIOUS INJURY WERE REPORTED DUE TO THE MALFUNCTION AND THE PHYSICIAN TRANSITIONED TO AN ALTERNATIVE EMBOLIC AGENT TO COMPLETE THE PROCEDURE. THOUGH THERE WAS NO DEATH OR SERIOUS INJURY IN THIS EVENT, A MDR HAS BEEN FILED OUT OF AN ABUNDANCE OF CAUTION, DUE TO THE POTENTIAL FOR DEATH OR SERIOUS INJURY OF UNCONTROLLED HEMORRHAGE IF THE MALFUNCTION CAUSED THE PATIENT TO NOT BE TREATED OR FOR THE DELAY IN PROCEDURE. BATCH RECORD REVIEW SHOWED THE DEVICE WAS MANUFACTURED TO RELEASED SPECIFICATIONS AND HAD PASSING QUALITY TEST RESULTS. SIRTEX HAS CONFIRMED THAT THE DEVICE WILL NOT BE RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    DURING A PERIPHERAL EMBOLIZATION PROCEDURE, THE PHYSICIAN AND IR STAFF WERE UNABLE TO FULLY EXTRACT THE LABELED 2.0 ML VOLUME FROM A LAVA 2 ML VIAL. DESPITE FOLLOWING STANDARD PREPARATION STEPS AND EMPLOYING COMMONLY USED TECHNIQUES TO MAXIMIZE VIAL EXTRACTION, ONLY APPROXIMATELY 1.5 ML OF PRODUCT COULD BE WITHDRAWN. THE PHYSICIAN REQUIRED THE FULL 2.0 ML TO COMPLETE THE PLANNED EMBOLIZATION. DUE TO THE INSUFFICIENT RETRIEVABLE VOLUME, THE PHYSICIAN WAS REQUIRED TO TRANSITION TO AN ALTERNATIVE EMBOLIC AGENT TO COMPLETE THE PROCEDURE. THIS RESULTED IN: ADDITIONAL PROCEDURAL TIME, USE OF AN ADDITIONAL EMBOLIC DEVICE, AND INCREASED PROCEDURAL COST TO THE FACILITY. NO USER ERROR WAS IDENTIFIED BY THE PHYSICIAN OR STAFF DURING PREPARATION OR EXTRACTION. THE PHYSICIAN SUGGESTED CONSIDERING FILLING THE VIAL WITH THE FULL LABELED 2.0 ML OR A SLIGHT OVERFILL TO ENSURE THAT THE FULL 2.0 ML CAN BE CONSISTENTLY WITHDRAWN INTO SYRINGES FOR DELIVERY DURING PROCEDURES. THERE WAS NO NEGATIVE OUTCOME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616324 LAVA-18, 2 ML Embolization Agent, Vascular QVG SIRTEX MEDICAL, INC. SLLES182 9000221 00850055697003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown