Events

Alerte De Sécurité sur Commercial name: Aortic Valve Prosthesis Pre-assembled Transcatheter in the Introducer System - LotusTM Valve - ANVISA registration number: 10341350785 - Risk class: IV - Maximum risk - Model affected: All. Serial number affected: All

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 Boston Scientific do Brasil; Boston Scientific Limited..

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
    1913
  • Date
    2016-04-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Boston Scientific of Brazil informs that for the unit to be designated as independent, it should have completed the following: 1. Two doctors must be certified. To do so, they must have: a. Participated in face-to-face training; B. Performed at least 6 Lotus Valve procedures with a Prospective and Clinical Field Expert (FSC) from Boston Scientific; or performed at least 4 additional Lotus Valve procedures with a Boston Scientific Field Clinical Specialist (FSC). 2. Two members of the cath lab should be certified to prepare the Lotus Valve; 3. Certified physicians must be trained in Advanced Techniques by Boston Scientific of Brazil. If the unit is not independent, procedures should not be performed with the Lotus Valve without the support of a Boston Scientific Field Clinical Specialist (FSC).
  • Cause
    The company has identified the occurrence of procedures with the lotus valve without the mandatory support of a clinical field specialist (fsc) until the hospital is designated as "independent" by boston scientific.
  • Action
    Security Alert. Code 2016-011 (Letter to Clients in Attachment)

Device

Commercial name: Aortic Valve Prosthesis Pre-assembled Transcatheter in the Introducer System - L...

Manufacturer

Boston Scientific do Brasil; Boston Scientific Limited.
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    ANVSANVISA