BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPLEX COSMOS

    MDR report key: 4617911 · Received March 19, 2015

    Report

    Report Number
    2032493-2015-00036
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Report Date
    January 5, 2015
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    COILING TREATING OF A SUBARACHNOID HEMORRHAGE (SAH) ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM). IT WAS REPORTED THE COIL COULD NOT BE DETACHED DURING PROCEDURE. UPON REMOVAL, THE COIL DETACHED WITHIN THE MICROCATHETER. A NEW MICROCATHETER AND COIL WAS PLACED SUCCESSFULLY. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186415 MICROPLEX COSMOS EMBOLIZATION COIL HCG MICROVENTION, INC. 100522CSSR-V 14062313

    Patients

    Seq Age Sex Outcome Treatment
    1