Events

Retiro De Equipo (Recall) de THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION CATHETER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    Recall
  • ID del evento
    25953
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-10-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Biosense webster has observed 34 complaints with a frequency of 0.03% related to a bend/crack at different locations of the shaft of the thermocool smarttouch catheter between january 2012 and july 2014. none of these complaints were associated with adverse events. manual pre-shaping of the distal shaft of the catheter and use of 8 fr sheaths were identified as the two primary causes of these events. the purpose of the field safety notice is to reinforce the warnings and precautions and directions for use in the current ifu as well as to notify customers of upcoming updates to the ifu's warnings and precautions.

Device

THERMOCOOL SMARTTOUCH BI-DIRECTONAL NAVIGATION CATHETER
  • Modelo / Serial
    Model Catalog: D132705 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132704 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132701 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132702 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D132703 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133603 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133601 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: D133602 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Descripción del producto
    THERMOCOOL SMARTTOUCH CATHETER (BI-DIR)
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    HC