BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC INFUSION CATHETER

    MDR report key: 8854681 · Received August 2, 2019

    Report

    Report Number
    8854681
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 25, 2019
    Manufacturer
    BALT USA LLC
    Product Code
    KRA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING EMBOLIZATION OF AN ARTERIOVENOUS MALFORMATION (AVM) WITH ONYX, STAFF NOTED THE ONYX WAS LEAKING OUT OF THE MID-PORTION OF THE MAGIC 1, 2FM CATHETER DURING THE 3RD INJECTION. THE ONYX SHOULD EXIT THE CATHETER AT THE TIP, NOT FROM THE MID-PORTION. THE PHYSICIAN HAD TO EMPLOY A SOLITAIRE DEVICE AND USE ASPIRATION TO RETRIEVE THE ONYX. PER THE OP NOTE, APPROXIMATELY 60% WAS RECAPTURED. A 2ND PHYSICIAN WAS CALLED IN TO ASSIST. MDS WORKED APPROXIMATELY 2.5 HOURS TO CORRECT THE ISSUE. ATTEMPTS WERE EVENTUALLY STOPPED TO PREVENT FURTHER HARM TO THE PATIENT. AS A RESULT OF THE EVENT, THE PATIENT HAS A LARGE RIGHT FRONTAL STROKE. SINCE THE EVENT, HE HAS DEVELOPED AN INTRACRANIAL HEMORRHAGE REQUIRING A CRANIECTOMY FOR DECOMPRESSION & HEMATOMA EVACUATION. HE REMAINS IN ICU WITH A POOR NEUROLOGICAL EXAM AND POOR PROGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651805 MAGIC INFUSION CATHETER CATHETER, CONTINUOUS FLUSH KRA BALT USA LLC MAGIC1,2FM 00302942

    Patients

    Seq Age Sex Outcome Treatment
    1 16060 DA Hospitalization| L| R| S