Events

Safety Alert for HYDROFILIC COVERING PTCA GUIDE FOR PTCA

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
    842
  • Date
    2006-09-11
  • 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
    Boston Scientific does the following guidelines: Immediately discontinue use and segregate affected units. - Immediately remove all affected batches from your inventory, rooms for special procedures, interventional radiology, OR, hemodynamics, central service, dispatch, receipt or any other location. - Segregate the affected units in a safe place and return them to Boston Scientific of Brazil. - All returned products will be replaced. The distribution or use of any remaining product affected should be terminated immediately. The Company further clarifies that this action does not affect any other PT2 Guide Wire in addition to the lots reported. To view the list of affected lots, go to: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2006/842.pdf UPDATE: 491 affected units of the product were collected in Brazil and sent to the Boston distribution center Scientific Corporation located in Quincy, United States, on November 14, 2006, as proof of re-export filed by the company.
  • Reason
    J-tip guidewires may be missing the prong of the j-tip. as a result, the guidewires of the affected batches may have a straight slope rather than a prong of the j-tip. the risk associated with this problem is a potential delay in the procedure when the difference in tip slope shape is identified and the product is replaced.
  • Action
    Boston Scientific do Brasil Ltda informs that corrective measures are being implemented and product replacement will be provided for all items collected.

Device

HYDROFILIC COVERING PTCA GUIDE FOR PTCA

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA