BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PGLA HELIX DETACHABLE COIL

    MDR report key: 1963756 · Received December 22, 2010

    Report

    Report Number
    2029214-2010-00273
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 7, 2010
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION AND THE IMPLANT COIL WAS FOUND DETACHED. BASED ON THE INVESTIGATION, THE COIL DETACHED DUE TO EXCESSIVE FORCE EXERTED ON THE COIL WHILE PULLING IT OUR OF THE CATHETER. (B)(4).

    Description of Event or Problem · 1

    COILING TREATMENT OF A RIGHT P-COM ANEURYSM. IT WAS REPORTED THE COIL WAS PARTIALLY DEPLOYED INSIDE THE ANEURYSM AND THEN PULLED BACK FOR REPOSITIONING. THE COIL COULD NOT BE ADVANCED OR WITHDRAWN AND EVENTUALLY DETACHED INSIDE THE CATHETER. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM PGLA HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR PC-2-3-HELIX 8183511

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN