BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPLEX COMPASS 18-SYSTEM COIL

    MDR report key: 3962628 · Received July 15, 2014

    Report

    Report Number
    2032493-2014-00062
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 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 PERFORMED AS THE SAMPLE HAS NOT YET BEEN RETURNED. HOWEVER, IT IS SAID TO BE AVAILABLE. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED AT THIS TIME. 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 ADVANCING THE COIL INTO THE ANEURYSM, RESISTANCE WAS ENCOUNTERED AND THE COIL PREMATURELY DETACHED. THE COIL WAS RETRIEVED SUCCESSFULLY USING A SNARE. NO HARM WAS REPORTED. PATIENT INFORMATION - PATIENT IDENTIFIER, AGE, SEX AND WEIGHT ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412267 MICROPLEX COMPASS 18-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. 181030CM-V 13100114

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention