BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR PERIPHERAL 18-SYSTEM COIL

    MDR report key: 3761078 · Received April 10, 2014

    Report

    Report Number
    2032493-2014-00037
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE COULD NOT BE PERFORMED AS IT WAS REPORTED TO NOT BE AVAILABLE DUE TO INFECTIOUS VIRUS EXPOSURE. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE DEVICE HISTORY WAS REVIEWED AND DID NOT REVEAL ANY ABNORMAL DISCREPANCIES OR NON-CONFORMANCES.

    Description of Event or Problem · 1

    DURING THE POSITIONING OF THE EMBOLIZATION COIL, THE COIL WAS NOT RESPONSIVE. THE MICROCATHETER WAS RETRACTED AND IT WAS OBSERVED THAT THE COIL PREMATURELY DETACHED PARTIALLY IN THE MICROCATHETER. THE COIL WAS RETRIEVED USING AN ENDOVASCULAR SNARE SUCCESSFULLY. NO HARM WAS REPORTED. PT INFORMATION - PT IDENTIFIER, AGE, SEX AND WEIGHT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216240 AZUR PERIPHERAL 18-SYSTEM COIL EMBOLIZATION COIL HCG MICROVENTION, INC. AZ80620HD 13041549

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention