Alerte De Sécurité sur Commercial Name: Atlas Gold Dilatation Catheter. Technical name: Balloon catheter for peripheral angioplasty. ANVISA registration number: 80689090119. Class of risk: II. Model Affected: ATG120164 / ATG120202 / ATG120242. Serial numbers affected: 93NB0051 / 93NB0052 / 93YA0086 / 93YA0036

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 Bard Brasil Indústria e Comércio de Produtos Medicos Ltda.; Bard Peripheral Vascular Inc..

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.

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  • Type d'événement
    Safety alert
  • ID de l'événement
    2411
  • Date
    2017-10-30
  • 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
    Contact Bard Brasil if there is any interest in replacing the products. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/29/2017 - Date of notification notice to Anvisa: 11/01/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    The manufacturer has identified that some cat gold atlas catheter product codes / batches may present a risk of having the wall thickness of the balloon exceeding the required specification. with this upper wall thickness of the balloon, there may be a small increase in the force required to advance the balloon through the sheath, and / or to withdraw the balloon after inflation and deflation, which may lead to a possible prolongation of the procedure. another possible effect may be an increase in balloon non-complacency or stiffness, but is unlikely to have a negative effect or an additional risk of injury during use.
  • Action
    Field Action Code VT-RAP-17-06-001 triggered under the responsibility of the company Bard Brasil Indústria e Comércio de Produtos Medicos Ltda .. Voluntary Field Action - Customer Notification.