BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEAD BLOCK

    MDR report key: 2190176 · Received May 9, 2008

    Report

    Report Number
    1067143-2008-00002
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 29, 2008
    Manufacturer
    BIOCURE, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT, A (B)(6) OLD KNOWN FOR BRONCHIAL DILATATION, WAS TREATED WITH BROCHIAL EMBOLIZATION FOR MODERATE RECURRENT HAEMOPTYSIS USING 300-500MICRON BEAD BLOCK THROUGH A 2.7FR PROGREAT CATHETER. THE EMBOLIZATION WAS PERFORMED AS AN EMERGENCY ON (B)(6) 2008 WITH SUPERSELECTIVE CATHETERIZATION OF THREE BRONCHIAL ARTERIES: TWO ON THE RIGHT SIDE (SUPERIOR AND INFERIOR) AND ONE ON THE LEFT SIDE (INFERIOR). THE PATIENT PRESENTED WITH NEUROLOGICAL DISORDER SEVERAL HOURS POST PROCEDURE. AN MRI ON (B)(6) SHOWED SPINAL INFARCT WITH HIGH SIGNAL INTENSITY. THERE WAS PROGRESSION OF THE NEUROLOGICAL DISORDER OVER THE FOLLOWING DAYS WITH AN INCREASE IN THE HIGH SIGNAL ON THE MRI OF THE SPINAL CORD PERFORMED A FEW DAYS LATER. THE PHYSICIAN HAS MANY YEARS EXPERIENCE OF BRONCHIAL EMBOLIZATION, HOWEVER THIS WAS THE FIRST CASE CARRIED OUT BY THE PHYSICIAN WITH BEAD BLOCK (HE USUALLY USES ANOTHER SPECIAL EMBOLIC AGENT IN THIS INDICATION). THE MANUFACTURER WAS NOTIFIED OF THE EVENT ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAD BLOCK BEAD BLOCK HCG BIOCURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening