BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAVA-18, 6 ML

    MDR report key: 18793552 · Received February 27, 2024

    Report

    Report Number
    3015355651-2024-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    February 19, 2024
    Report Date
    June 5, 2024
    Manufacturer
    BLACKSWAN VASCULAR, INC.
    Product Code
    QVG
    UDI-DI
    00850055697027
    PMA / PMN Number
    P220020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS (DHR) REVIEW SHOWED NO ABNORMALITIES AND THAT THE PRODUCT MET THE PRODUCTION ACCEPTANCE CRITERIA PER ESTABLISHED MANUFACTURING PRODUCTION INSTRUCTIONS. THE RECORDS ALSO SHOW THAT THE SUB-ASSEMBLY PRODUCTION PARTS MET THE REQUIREMENTS AND SPECIFICATIONS PER ESTABLISHED MANUFACTURING REQUIREMENTS, SUCH AS STERILIZATION & VERIFICATION BY ANALYTICAL LABORATORY AND VISCOSITY MEASUREMENT. THE PRODUCT LOT PASSED VISUAL INSPECTIONS OF THE LES SERUM VIALS AND PASSED THE LEAK TEST. THE DEVICE WAS NOT RETURNED, SO NO FURTHER INVESTIGATION CAN BE COMPLETED.

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURING DATA AND OTHER DETAILS ARE CURRENTLY BEING EVALUATED TO DETERMINE ROOT CAUSE. IT IS NOT CURRENTLY KNOWN WHETHER THE INCIDENT OCCURRED DUE TO DEVICE MALFUNCTION OR OTHER CAUSE(S). THERE WAS NO ADVERSE IMPACT TO PATIENT.

    Description of Event or Problem · 0

    PHYSICIAN WAS USING A 6 ML LAVA VIAL FOR AN OFF LABEL USE AND COULD ONLY GET 5.0 ML OUT OF THE VIAL. DIFFERENT ANGLES AND NEEDLES WERE TRIED TO GET THE LAVA OUT, BUT PHYSICIAN COULD NOT GET ANY MORE PRODUCT OUT OF THE VIAL. PHYSICIAN COMPLETED PROCEDURE BY USING COILS SINCE NO ADDITIONAL LAVA PRODUCT WAS AVAILABLE ON SITE. PATIENT WAS NOT AFFECTED. THE REPORT STATES, "PATIENT DID FINE.".

    Description of Event or Problem · 0

    PHYSICIAN WAS USING A 6 ML LAVA VIAL FOR AN OFF LABEL USE AND COULD ONLY GET 5.0 ML OUT OF THE VIAL. DIFFERENT ANGLES AND NEEDLES WERE TRIED TO GET THE LAVA OUT, BUT PHYSICIAN COULD NOT GET ANY MORE PRODUCT OUT OF THE VIAL. PHYSICIAN COMPLETED PROCEDURE BY USING COILS SINCE NO ADDITIONAL LAVA PRODUCT WAS AVAILABLE ON SITE. PATIENT WAS NOT AFFECTED. THE REPORT STATES, "PATIENT DID FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444825 LAVA-18, 6 ML LAVA LIQUID EMBOLIC SYSTEM QVG BLACKSWAN VASCULAR, INC. SLLES186 10518 00850055697027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown