Events

Alerte De Sécurité sur nMARQ Circular Irrigated 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
    2015-07-03
  • Date de publication de l'événement
    2015-07-03
  • 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_20150703.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 webster nmarq circular irrigated catheter medical device manufacturer, biosense webster, has issued a medical device safety alert concerning nmarq circular irrigated catheter [catalogue number: d132214, lot number: all]. the manufacturer has recently 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, they have 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-esophageal fistula (aef). extensive ablation on the left atrial posterior wall may have been the main contributing factor to the aefs in these two cases of persistent atrial fibrillation that were treated by pulmonary vein isolation and left atrial posterior wall ablation. according to the manufacturer, no direct link could be confirmed between the low temperature issue and the aef as it was detected in only one of the two confirmed aef cases. therefore, the low temperature issue may be a secondary risk factor as it may affect power titration and delivery during radio frequency ablation. the manufacturer decided to conduct a removal for all lots of the nmarq circular irrigated catheter distributed since 2 february 2015 and conduct a full investigation. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 july 2015.

Device

nMARQ Circular Irrigated Catheter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosense Webster nMARQ Circular Irrigated Catheter
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster