BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2493762 · Received March 12, 2012

    Report

    Report Number
    2954740-2012-00025
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 23, 2012
    Report Date
    February 23, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RECEIVED WITHIN OUR FACILITY AT THIS POINT. A FOLLOW UP REPORT IS GOING TO BE SUBMITTED AS SOON AS THE DEVICE IS RECEIVED AND FINAL ANALYSIS HAS BEEN CONDUCTED.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: DUE TO INCORRECT SIZE SELECTION, THE PHYSICIAN DECIDED TO REMOVE THE COIL. DURING WITHDRAWAL, AN "UNRAVELED FEELING" WAS EXPERIENCED AND FOUND OUT THAT THE COIL HAD UNINTENTIONALLY DETACHED IN THE ANEURYSM (NO DETACHMENT ATTEMPTED). THE COIL WAS SAFELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION F59039

    Patients

    Seq Age Sex Outcome Treatment
    1