BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL EMBOLIZATION COIL

    MDR report key: 18247382 · Received November 30, 2023

    Report

    Report Number
    MW5148643
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    November 28, 2023
    Report Date
    November 28, 2023
    Manufacturer
    BALT USA, LLC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INITIALLY LOADED AND DEPLOYED BALT 4 X 10 MM DETACHABLE COIL FAILED TO DETACH FROM DELIVERY SYSTEM. THE ENTIRE MICROCATHETER AND COIL DEVICE HAD TO BE REMOVED. THERE WAS NO ADDITIONAL TREATMENT NECESSARY AND EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH A SAME SIZED CONCERTO COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73155 PERIPHERAL EMBOLIZATION COIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG BALT USA, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention