BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO DETACHABLE COIL SYSTEM

    MDR report key: 21167484 · Received January 16, 2025

    Report

    Report Number
    21167484
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 20, 2024
    Report Date
    January 9, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CONCERTO COILS GOT LODGED IN A PROGREAT MICROCATHETER. 1. NV-2-4-HELIX, LOT# 228484485. 2. NV-2-8-HELIX, LOT# 228392637. 3. NV-2-8-HELIX, LOT#228045527.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892645 CONCERTO DETACHABLE COIL SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MICRO THERAPEUTICS, INC. NV-2-4-HELIX, NV-2-8-HELIX 228484485, 228392637, 22804552

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose