BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL EMBOLIZATION COIL

    MDR report key: 23680375 · Received December 1, 2025

    Report

    Report Number
    MW5179582
    Event Type
    Malfunction
    Date Received
    December 1, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BALT USA, LLC.
    Product Code
    KRD
    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

    EMBOLIZATION COIL WOULD NOT DETACH. IMPLANTED AND EXPLANTED. NO HARM TO PATIENT. VENDOR NOTIFIED AND COIL BEING REPLACED FREE OF CHARGE. UNFORTUNATELY, THE DEFECTIVE COIL WAS THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078986 PERIPHERAL EMBOLIZATION COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BALT USA, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other