BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX 10-SYSTEM COIL (MCS)

    MDR report key: 3810022 · Received April 30, 2014

    Report

    Report Number
    2032493-2014-00046
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE HAS NOT BEEN RETURNED TO DATE. WE HAVE INQUIRED REGARDING THE RETURN STATUS OF THE SAMPLE. WHEN THE SAMPLE IS RETURNED WE REPORT OUR FINDINGS IN A FOLLOW-UP REPORT. 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 A COIL WITHIN AN ANEURYSM, IT PREMATURELY DETACHED. THE COIL WAS PUSHED IN THE ANEURYSM USING THE DELIVERY PUSHER. NO RETRIEVAL ATTEMPTS WERE MADE. NO HARM WAS REPORTED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259164 MICROPLEX 10-SYSTEM COIL (MCS) EMBOLIZATION COIL HCG MICROVENTION, INC. 100410HC-S-V 14012213

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention