BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX 10-SYSTEM COIL

    MDR report key: 3121927 · Received May 15, 2013

    Report

    Report Number
    2032493-2013-00025
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE HAS NOT BEEN PERFORMED AS IT HAS NOT BEEN RETURNED TO DATE. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. AN ANALYSIS WILL BE PERFORMED ONCE THE PRODUCT IS RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCE WERE OBSERVED. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEPLOYING A COIL WITHIN THE RIGHT ACI, THE COIL STRETCHED. THE COIL WAS PARTIALLY WITHIN THE ANEURYSM AND THE MICROCATHETER. THE PORTION OF THE COIL THAT CAME OUT OF THE ANEURYSM WAS FIXED IN PLACE WITH AN ENTERPRISE STENT. NO HARM WAS REPORTED. PT INFO - PT IDENTIFIER, AGE, SEX AND WEIGHT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214660 MICROPLEX 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100608HS-V 121206H8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention