BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE COIL SYSTEM

    MDR report key: 19537513 · Received June 13, 2024

    Report

    Report Number
    MW5156258
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 11, 2024
    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

    AS COIL WAS BEING IMPLANTED IT DETACHED FROM THE SYSTEM AND ONCE IT WAS BEING RETRIEVED, IT STRETCHED. BALT PRESTIGE COIL SYSTEM, PRES0865HPKPL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687940 PRESTIGE COIL SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BALT USA, LLC PRES0865HPKPL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other