Events

Safety Alert for IMPULSE ANGIOGRAPHIC CATHETER and WISEGUIDE CATÉTER GUIA - Registered at Anvisa under the numbers 10341350402 and 10341350445 - Models / Lots: See attached list.

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
    978
  • Date
    2009-09-02
  • 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
    The company is aware that hospitals often remove the products from their outer cartons and store them on the shelves, only in their inner pouches. If this is a practice in your unit, it is very important that you carefully use the enclosed product listing and consider both the internal and the external code of the packaging of the affected products in this collection, as the UPN numbers on the labels of packaging may be different from those on the outer packaging labels. The product information listed on your specific Verification and Traceability Response Form only provides the code for the product's external packaging and is the code that should be used when reporting localized products for return. Check the batch number of the product with the complete product listing to determine if the batch present in your stock is affected. If so, indicate on your Verification and Traceability Response Form the number of units for each batch you are required to return. Since some products within this family of products are sold individually, others in packs of 5 and multi-packs of 3 or 5 catheters, it is important that all reported quantities represent the actual number of individual catheters that are being returned and not the number of boxes or multi-packs. (source: Boston Scientific of Brazil Ltda.) Regulatory authorities around the world affected by this voluntary recall are being notified. The company expects to complete the collection until 10/16/2009. Anvisa is accompanied by this action.
  • Reason
    The manufacturer of the product has announced the possibility of compromising the sterile barrier of some packaging. during internal inspections, cracks were observed between the side seals and the upper sealing of some packages. if a compromised sealant catheter is used, there is a risk of adverse health consequences, including bacteremia or infection.
  • Action
    The actions recommended to users of the product are as follows: (1) Immediately stop the use of products listed in the attached list; (2) Locate products with the affected models / batches in your inventory and segregate them. (2) Return them to the dealer for disposal. (3) Forward the Verification and Traceability Response Form to Boston Scientific do Brasil Ltda. - A / C Caroline Yin - Fax: (011) 5502-8510; (4) Request collection by calling (011) 5502-8583.

Device

IMPULSE ANGIOGRAPHIC CATHETER and WISEGUIDE CATÉTER GUIA - Registered at Anvisa under the numbers...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA