Events

Safety Alert for Electro-Hemostasis Catheter Disposable Bipolar GOLD PROBE. Reg. Anvisa: 10341350350. Lots Affected: See annex Letter to the Clients (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/954_carta.pdf).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    954
  • Date
    2009-02-03
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Boston Scientific do Brasil Ltda has already started collecting the product. The problem was detected by Boston Scientific Corporation during a quality inspection performed by the company. The Technovigilance Unit is following up on this case.
  • Reason
    The packaging tray of some units may be broken, which compromises the sterile barrier of the product. if used, the potential effect for the patient may be infection.
  • Action
    Users of the product in question shall: (1) Immediately discontinue use and segregate the collected product; (2) Complete the Verification and Traceability Response Form; (3) Pack / send the affected product. To access the Form of Traceability provided by the company: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/954_formulario.pdf.

Device

Electro-Hemostasis Catheter Disposable Bipolar GOLD PROBE. Reg. Anvisa: 10341350350. Lots Affecte...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA