BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCS COMPLEX FILL 4 X 10

    MDR report key: 779010 · Received November 7, 2006

    Report

    Report Number
    1058196-2006-00194
    Event Type
    Injury
    Date Received
    November 7, 2006
    Date of Event
    October 10, 2006
    Report Date
    November 7, 2006
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION WITHIN AN UNKNOWN ANEURYSM, ONE GDG COIL AND SIX DCS COILS WERE PLACED WITHOUT DIFFICULTY. DURING PLACEMENT OF THE 7TH DCS COIL WHILE POSITIONING THE COIL, THE TIP OF THE MICROCATHETER SPRANG AND THE COIL WAS DETACHED PREMATURELY. THE DISTAL PART OF THE COIL WAS INSERTED INTO THE ANEURYSM. THE PROXIMAL PART OF THE COIL HAD PROTRUDED OUT OF THE ANEURYSM INTO THE PARENT ARTERY. THE PATIENT STATUS WAS REPORTED AS STABLE. THE PHYSICIAN ATTEMPTED TO PLACE THE 8TH COIL DUE TO THE PROTRUSION OF THE 7TH COIL, BUT WAS UNSUCCESSFUL. REPORTEDLY, THERE WAS ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE. CONTINUOUS FLUSH WAS MAINTAINED WITHIN THE MC. THERE WAS NO DIFFICULTY EXPERIENCED WITH THE MC STABILITY PRIOR TO THIS EVENT. THERE WAS NO RESISTANCE WHEN THE COIL WAS REPOSITIONED/WITHDRAWN. THE PRODUCT WAS PREPARED AS PER THE IFU. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCS COMPLEX FILL 4 X 10 CNV DCS COILS HCG CORDIS NEUROVASCULAR, INC. NA 13094574

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN