Events

Alerte De Sécurité sur THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Biosense Webster.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-04-15
  • Date de publication de l'événement
    2014-04-15
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140415a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: biosense webstar thermocool sf nav diagnostic/ablation deflectable tip catheter the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning thermocool sf nav diagnostic/ablation deflectable tip catheter, manufactured by biosense webster. the manufacturer has identified a higher frequency of spontaneously reported adverse events related to cardiac perforations and atrio-esophageal fistula (aef) with the uni-directional and bi-directional thermocool sf nav catheter family during the time period of january 2010 to december 2013 as compared to other navigational thermocool ablation catheters. the manufacturer has not yet identified a definitive cause for this observed difference in frequency of adverse events for the uni-directional and bi-directional thermocool sf nav catheter family. meanwhile, the manufacturer advises that two factors should be considered in relation to these reported adverse events: the increased stiffness and the related handling properties of the thermocool sf nav catheter family may contribute to the risk for perforation. due to the enhanced cooling feature of the thermocool sf nav catheter, application of the same power settings, guided by temperature feedback, as previously used with other navigational thermocool catheters may result in relatively deeper lesions and potentially contributes to higher rate of aef and cardiac perforations. the manufacturer also reminds users to pay special attention on relevant warnings and precautions in the instructions for use (ifu) for the thermocoolsf nav catheter family models. according to the local supplier, johnson & johnson (hong kong) ltd, the affected products were distributed in hong kong. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con402544 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 15 april 2014.

Device

THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosense Webstar THERMOCOOL SF NAV Diagnostic/Ablation Deflectable Tip Catheter
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster