Events

Safety Alert for MICROCATETER EXCELSIOR SL-10. Registration with Anvisa: 10341350362. Lots Affected: check at the electronic address http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_945_Produtos_afetados.pdf

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

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
    945
  • Date
    2008-10-30
  • 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
    To date, Boston Scientific Corporation has received no complaint in connection with this product issue. No adverse events were reported to Boston Scientific Corporation. The attached table provides a complete list of all the products being collected.
  • Reason
    According to information from the company holding the record, the packaging of the product may potentially fail in maintaining its sterile barrier and its shelf life. the failure in the sterile barrier of the product packaging was identified during routine testing, appeared to be larger than a needle hole and was visible to the naked eye. this fault has occurred in only one of the packaging of this product. lack of sterility has the potential to lead to infection. the infection can range from a transient, sub-clinical infection to a systemic infection or abscess. infections, especially in the vasculature, have the potential to be severe. the most serious injury that can be reasonably expected to occur is a systemic infection.
  • Action
    The recommendations to customers of the products at risk are as follows: 1. Immediately interrupt the use and segregate the product (s) being collected; 2. Immediately remove all affected lots from the products being collected from the inventory; 3. Segregate in a safe place for return to Boston Scientific; 4.Fill and send the Verification / Traceability Form (even if you do not have any product to be returned), to Boston Scientific of Brazil. The Verification Form can be accessed at: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_945_formulario_verificacao_rastreabilidade.pdf

Device

MICROCATETER EXCELSIOR SL-10. Registration with Anvisa: 10341350362. Lots Affected: check at the ...

Manufacturer

Boston Scientific
  • Source
    ANVSANVISA