BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZUR PERIPHERAL COIL SYSTEM

    MDR report key: 3213228 · Received March 12, 2013

    Report

    Report Number
    2032493-2013-00014
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    September 28, 2012
    Report Date
    February 15, 2013
    Manufacturer
    MICROVENTION, INC.
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: AN EVALUATION OF THE ACTUAL COMPLAINT SAMPLE HAS NOT BEEN PERFORMED AS IT HAS NOT BEEN RETURNED BY THE USER CENTER. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ABNORMAL DISCREPANCIES OR NON-CONFORMANCE WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 MICROVENTION, INC. RECEIVED A MEDWATCH FORM VIA EMAIL FROM OUR (B)(4) OFFICE. THIS WAS OUR FIRST NOTIFICATION OF AN AZUR COMPLAINT. THE FOLLOWING IS THE DESCRIPTION OF THE FORM WE RECEIVED (REF. (B)(4)). COIL DID NOT DEPLOY PROPERLY. THE DEVICE WAS RETRIEVED AND A NEW COIL INSERTED. THERE WAS NO HARM TO THE PATIENT, BUT DID RESULT IN INCREASE OF TIME. THE PRODUCT WAS REPLACED WITH EQUIVALENT. OUR SALES REPRESENTATIVE AND FIELD ASSURANCE DEPT. HAVE MADE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE USER CENTER. HOWEVER, THIS HAS BEEN UNSUCCESSFUL TO DATE. ADDITIONAL ATTEMPTS WILL BE MADE. A COMPLAINT MATCHING THIS LOT NUMBER DESCRIPTION HAS NOT BEEN REPORTED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104979 AZUR PERIPHERAL COIL SYSTEM EMBOLIZATION COIL KRD MICROVENTION, INC. 12032312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention