Events

Safety Alert for Commercial Name: ENTERYX PROCEDURE KIT Registration ANVISA Nº 10341350381 -. Technical Name: Keratometer

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

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
    816
  • Date
    2005-10-11
  • 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
    NOTE: BOSTON SCIENTIFIC DO BRASIL LTDA informs that in BRASIL this product was not marketed since it was only used in training with specialists from BOSTON SCIENTIFIC CORPORATION. The 18 physicians who participated in the training and hospitals involved will be notified in a statement. If you have any questions regarding this announcement, please contact Boston Scientific do Brasil Ltda, at 11-5502 8500
  • Reason
    Boston scientific corporation has chosen to initiate a voluntary recall of all enteryx products. according to information of the company this action is related to the technique of the injection procedure and not to the safety and effectiveness of the product when properly implanted.
  • Action
    The company reports that it is collecting and analyzing an increasing number of data indicating that a transmural injection may occur despite the use of the fluoroscope throughout the procedure. Most transmural injections are recognized during the Enteryx procedure and or after the procedure through chest filming. He also reported that he was aware of 6 transmural injections that were not recognized during the procedure and immediately followed up. The most recent case involving a transmural injection resulted in a pleuropulmonary fistula. However, all these cases were recognized after 21 days of procedure. The possibility of a transmural injection through a vital organ is considered an unacceptable risk by Boston Scientific Corporation given the benign condition and other treatment options and as a result decided to collect the product from the market. If you have had any procedure with the Enteryx kit in the past month, we recommend that you follow up with your patient. Patients who had an unrecognized transmural injection had symptoms including epigastric pain, retrosternal pain (chest), respiratory tract infection (fever, cough, chest pain, difficulty breathing), pneumonia, syncopal episodes, and flank pain. If you feel that the presence of an unrecognized transmural injection needs to be evaluated, Boston Scientific Corporation will cover the additional costs of the imaging procedures required.

Device

Commercial Name: ENTERYX PROCEDURE KIT Registration ANVISA Nº 10341350381 -. Technical Name: Kera...

Manufacturer

BOSTON SCIENTIFIC CORPORATION
  • Source
    ANVSANVISA