BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS HELIX SUPER SOFT CSR DETACHABLE COIL

    MDR report key: 3033022 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00320
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 8, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE IMPLANT COIL WAS RETURNED AND THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.(B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT FRICTION WAS EXPERIENCED WHEN THE PHYSICIAN ADVANCED THE COIL THROUGH THE MICROCATHETER. UPON WITHDRAWAL OF THE COIL TO EXAMINE, IT WAS FOUND DETACHED OUTSIDE OF 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
    136771 NEXUS HELIX SUPER SOFT CSR DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR X-4-10-T10-HSS 7972974

    Patients

    Seq Age Sex Outcome Treatment
    1