BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELICAL DETACHABLE COIL

    MDR report key: 2840720 · Received November 20, 2012

    Report

    Report Number
    2029214-2012-00647
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY (A-COMM) ANEURYSM. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER OR VIA MANUAL METHOD (PROVIDED IN THE INSTRUCTION FOR USE) AND WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-8-HELIX 9546828

    Patients

    Seq Age Sex Outcome Treatment
    1