BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALT COIL

    MDR report key: 17652585 · Received August 29, 2023

    Report

    Report Number
    MW5145074
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 23, 2023
    Report Date
    August 25, 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

    DURING IMPLANTATION OF BALT COIL DURING EMBOLIZATION, THE BALT COIL GOT STUCK HALF IN/HALF OUT OF THE SWIFT NINJA CATHETER. DR (B)(6) REMOVED THE CATHETER OUT OF THE BODY TO RETRIEVE THE COIL. ENTIRE COIL WAS REMOVED AND NO COIL WAS LEFT INSIDE THE BODY. BALT 1.5 MM X 8 CM COIL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182968 BALT COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BALT USA, LLC BALT 1.5 MM X 8 CM COIL

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Other