Retiro De Equipo (Recall) de Biosense Webster nMARQ Circular Irrigated Catheter

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Biosense Webster Inc.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    The manufacturer has received an increased number of complaints related to a low temperature measurement anomaly at electrodes of the nmarq® circular irrigated catheter., during the same time period, has also received three reports of deaths of patients who were treated with the nmarq® circular irrigated catheter. two of these cases were confirmed to be caused by atrio-oesophageal fistula., no direct link could be confirmed between the low temperature issue and the atrio-oesophageal fistula as it was detected in only one of the two confirmed cases. therefore, the low temperature issue may be a secondary risk factor as it may affect power titration and delivery during radio frequency ablation.As a result of these issues, biosense webster is recalling the nmarq® circular irrigated catheter and is conducting a full investigation.
  • Acción
    Product to be returned to supplier