BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSATILE RANGE FILL COIL (VFC)

    MDR report key: 2890653 · Received December 21, 2012

    Report

    Report Number
    2032493-2012-00056
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVAL OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS A PORTION REMAINS WITHIN THE PT AND THE REMAINDER OF THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE ROOT CAUSE OF THIS COMPLAINT CAN NOT 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 AN EMBOLIZATION COIL WITHIN AN ANEURYSM, THE COIL APPEARED NOT TO BE IN THE CORRECT POSITION. UPON MANIPULATION, THE COIL PREMATURELY DETACHED. AN ATTEMPT WAS MADE TO RETRIEVE THE COIL WITH A SNARE. IN DOING SO, THE COIL STRETCHED. AN ADD'L ATTEMPT WAS MADE WITH AN ALLIGATOR DEVICE UNSUCCESSFULLY AS THE COIL BROKE. THE REMAINING COIL WAS LEFT WITH APPROX 3CM OF COIL INTO THE ACI. NO HARM OR INJURY REPORTED. ON (B)(6) 2012, INFO WAS RECEIVED FROM THE PHYSICIAN THAT THE PT WAS DOING WELL WITHOUT RESTRICTION OF ANY KIND. THE ANEURYSM WAS CLOSED. A F/U EXAMINATION IS SCHEDULED IN 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSATILE RANGE FILL COIL (VFC) EMBOLIZATION COIL HCG MICROVENTION, INC. VFC030615-V 121031H5

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention