Alerte De Sécurité sur CATHEDRAL OF DILATACAO Rx PTCA - Registration number ANVISA: 80145900992 - Lots: 13315455 or smaller.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par CORDIS DE MEXICO SA DE CV; CORDIS EUROPA, NV.

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
  • ID de l'événement
    901
  • Date
    2008-01-29
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    The current worldwide complaint rates are 0.03% for Fire Star angioplasty catheters and 0.008% for Dura Star angioplasty catheters. According to the company, in Brazil, no product complaint by any customer was received so far, 29.01.2008. Possibility of a "slow deflation" or "no deflation" during inflation of the catheter flask. If a catheter presents "no deflation" conditions in a coronary artery or coronary artery bypass, complete occlusion of the blood vessel may occur, potentially resulting in arrhythmias, including ventricular fibrillation, acute myocardial infarction, coronary artery injury or need for surgery. The company also reports that up to now, they have received five reports (outside Brazil) of ischemic episodes during procedures, however, no permanent injuries have been reported. According to company information were imported by J & J ;: 1749. Of this amount, 529 units were sent to customers and distributors. The remainder is held by J & J .;
  • Cause
    A small number of these catheters may have potential for "slow deflation" or "no deflation.
  • Action
    In Brazil, there is registration of import and distribution of lots affected by Johnson & Johnson Professional Products Uda. In order to ensure that the products in question are not used, the company in Brazil, in parallel with this notification, has already initiated the collection process with its customers and distributors and all affected products found in stock were blocked for sale and transferred to a location quarantine for further destruction.

Manufacturer