BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBCA LIQUID EMBOLIC KIT

    MDR report key: 634562 · Received September 12, 2005

    Report

    Report Number
    1058196-2005-00339
    Event Type
    Injury
    Date Received
    September 12, 2005
    Date of Event
    August 17, 2005
    Report Date
    September 12, 2005
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    MFE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN EMBOLIZATION OF A HIGH FLOW SPINAL ARTERIAL VENOUS MALFUNCTION (AVM). THE NBCA WAS MIXED WITH ETHIODIZED OIL 30% GLUE WITH 70% ETHIODIZED OIL. IT WAS REPORTED THAT AFTER MIXING THE SOLUTION THE PHYSICIAN TESTED THE MIXTURE WITH HIS FINGER, AND IT DID NOT FEEL STICKY. THE PROCEDURE CONTINUED. RADIOGRAPHIC IMAGES SHOW A GREATER THAN 3CM POUCH OF GLUE IN THE VENOUS SYSTEM. AFTER THE EMBOLIZATION THERE WAS NO OTHER SURGERY PERFORMED. THE PATIENT STILL HAS LOWER EXTREMITY PARALYSIS WHICH WAS NOT PRESENT PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBCA LIQUID EMBOLIC KIT CNV NBCA MFE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR