Events

Alerte De Sécurité sur PENTARAY Catheters

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
    2016-04-21
  • Date de publication de l'événement
    2016-04-21
  • 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_20160421.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 pentaray catheters medical device manufacturer, biosense webster, has issued a medical device safety alert concerning its pentaray catheters. this involves all lots of pentaray catheters with catalogue numbers d128201, d128202, d128203, d128204, d128205, d128206, d128207, 0128208, d128209, d128210, d128211, and d128212. pentaray catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.E., recording or stimulation only. this catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. the manufacturer is updating the contraindication language in the instructions for use (ifu) and product labeling for this catheter relative to patients with prosthetic valves. the current language in the ifu provides a precaution against use of the pentaray catheter in patients with prosthetic valves under the contraindication section stating: “[the] use of this catheter may not be appropriate for use in patients with prosthetic valves.” the manufacturer is updating the contraindication statement as follows: “do not use pentaray catheters in patients with prosthetic valves”. according to the manufacturer’s medical assessment, there is a high risk of catheter spline entanglement when using pentaray catheters in patients with prosthetic valves. if excessive force is applied on the entangled catheter spline, there is a potential for parts to detach and embolize inside the patient’s body, which may lead to serious complications like stroke, transient ischemic attack, myocardial infarction or pulmonary embolism. the likelihood of these serious complications remains low. the manufacturer advises users that they may continue to use pentaray catheters in accordance with the updated contraindication. 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 21 april 2016.

Device

PENTARAY Catheters
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Biosense Webster PENTARAY Catheters
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster