BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSATILE RANGE FILL COIL SYSTEM

    MDR report key: 4032057 · Received August 1, 2014

    Report

    Report Number
    2032493-2014-00066
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE HAS NOT BEEN PERFORMED AS THE SAMPLE REMAINS WITHIN THE PATIENT AND THE DELIVERY PUSHER WAS REPORTED UNAVAILABLE. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON POSITIONING THE COIL IN THE ANEURYSM, THE COIL STRETCHED. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL USING A LASSO. HOWEVER, THE COIL COULD NOT BE RETRIEVED AND IT APPEARED THE COIL BROKE. A FRED DEVICE WAS USED TO KEEP THE COIL IN PLACE AGAINST THE VESSEL WALL SUCCESSFULLY. WE HAVE REQUESTED ADDITIONAL INFORMATION AS ALL THE INCIDENT DETAILS AND PATIENT STATUS WERE NOT KNOWN WHEN THE INCIDENT WAS INITIALLY REPORTED. NO HARM WAS REPORTED. PATIENT INFORMATION - PATIENT IDENTIFIER, SEX, AGE AND WEIGHT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450166 VERSATILE RANGE FILL COIL SYSTEM EMBOLIZATION COIL HCG MICROVENTION, INC. VFCO30615-V 140107HS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R