Events

Alerte De Sécurité sur Lariat Suture Delivery Device

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

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
    2015-07-14
  • Date de publication de l'événement
    2015-07-14
  • 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_20150714.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: sentreheart lariat suture delivery device the united states food and drug administration (fda) has issued medical device safety alerts concerning lariat suture delivery device, manufactured by sentreheart. the fda is alerting health care providers and patients of reports of patient deaths and other serious adverse events associated with the use of the lariat suture delivery device and its associated devices to close the left atrial appendage, a pouch-like region of the left atrium in the heart, in patients with irregular heart rhythm (atrial fibrillation) to prevent stroke. the fda identified 45 adverse events through june 30, 2015 that occurred in patients undergoing left atrial appendage (laa) closure procedures with the lariat suture delivery device and/or its associated devices. these reports describe six patient deaths and other serious medical complications including laceration and/or perforation of the heart, complete laa detachment from the heart, bleeding (hemorrhage), low blood pressure (hypotension), fluid collection around the heart (pericardial effusion), fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock (cardiac tamponade), and fluid collection around the lung (pleural effusion). of the 45 adverse events reported to the fda, 34 (approximately 75%) resulted in the need to perform emergency heart surgery. to reduce the risk of stroke in patients with atrial fibrillation, the fda advises healthcare professionals to consider treatment options for which safety and effectiveness have been established. prior to treatment, health professionals should inform atrial fibrillation patients of the benefits and risks of the available treatment options to help prevent stroke. for details, please refer to the fda websites: http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ucm454501.Htm http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm454660.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 july 2015.

Device

Lariat Suture Delivery Device
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SentreHEART Lariat Suture Delivery Device
  • Manufacturer
    SentreHEART

Manufacturer

SentreHEART