BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX (MCS) 10-SYSTEM COIL

    MDR report key: 2171306 · Received June 21, 2011

    Report

    Report Number
    2032493-2011-00015
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 21, 2011
    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: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. 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 DURING ADVANCEMENT OF AN EMBOLIZATION COIL THROUGH A MICROCATHETER, THE COIL STRETCHED AND PREMATURELY DETACHED. AN INTRAVASCULAR SNARE WAS USED TO REMOVE THE COIL SUCCESSFULLY. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPLEX (MCS) 10-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 100206HS-V 110408H8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention