Events

Retiro De Equipo (Recall) de Magellan Robotic System (Catheter controller steering unit )

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtel Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00341-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-04-16
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00341-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Hansen medical has recently become aware of an incident, which occurred during the catheter installation steps for peripheral vascular procedure. a magellan robotic catheter 6fr was manually inserted a short distance into the patient’s femoral artery, as required. however, during the subsequent catheter installation steps, system buttons were simultaneously pressed while removing, then reinstalling the guide wire support, which is a variation from the ifu instructions. during this sequence of steps, the user pressed a button to retract the catheter, installed the guide wire support, then released the button. the catheter did not stop retracting as expected when the button was released. instead, the system fully retracted the catheter, removing the introducer and patient patch along with the catheter, and vascular access was lost. this system behaviour can only occur during the catheter installation workflow and not during navigation or delivery of therapy.
  • Acción
    If this situation should occur, Medtel is requesting the users to press the Emergency Stop button as described in the Magellan Robotic System Instructions for Use (IFU). Medtel is also scheduling field safety training and re-training the Magellan physician-operator to the information contained herein.

Device

Magellan Robotic System (Catheter controller steering unit )
  • Modelo / Serial
    Magellan Robotic System (Catheter controller steering unit )Catalogue Number: 11139All Serial NumbersARTG Number: 194358
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Medtel Pty Ltd

Manufacturer

Medtel Pty Ltd
  • Source
    DHTGA