BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMA COIL SYSTEM 5MMX17CM

    MDR report key: 23597851 · Received November 19, 2025

    Report

    Report Number
    MW5179077
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    November 11, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BALT USA LLC
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A CEREBRAL ANEURYSM COILING, A BALT OPTIMA COIL STRETCHED, LEAVING THE END OF THE COIL OUTSIDE OF THE ANEURYSM WITHOUT SUPPORT TO PUSH IT INTO THE ANEURYSM. A STENT WAS PLACED ON THE STRETCHED PIECE TO SECURE IT TO THE ARTERIAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023823 OPTIMA COIL SYSTEM 5MMX17CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG BALT USA LLC F211100967

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown