BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALT PRESTIGE COIL SYSTEM PERIPHERAL EMBOLIZATION COIL

    MDR report key: 17745589 · Received September 13, 2023

    Report

    Report Number
    MW5145639
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    September 10, 2023
    Report Date
    September 11, 2023
    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

    OPENED THE BALT COIL PACKAGE AND TOOK THE HOOP OUT THEN REMOVED THE COIL. THE TIP OF THE COIL WAS HANGING OUT OF THE SHEATH AND WHEN TEAM ATTEMPTED TO PULL THE COIL BACK IN TO THE SHEATH IT BROKE. MANUFACTURER NOTIFIED. NO HARM- DEFECT OCCURRED PRIOR TO USING ON PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330738 BALT PRESTIGE COIL SYSTEM PERIPHERAL EMBOLIZATION COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BALT USA, LLC F230800312

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Other