BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALT COIL 3.5X30

    MDR report key: 17624485 · Received August 24, 2023

    Report

    Report Number
    MW5144966
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 22, 2023
    Manufacturer
    BALT USA, LLC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EMBOLIC COIL FAILED TO DEPLOY; COIL THROWN AWAY AT END OF CASE, INADVERTENTLY. BALT COIL 3.5X30.(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726685 BALT COIL 3.5X30 DEVICE, NEUROVASCULAR EMBOLIZATION HCG BALT USA, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other