Events

Safety Alert for CATEGORY ANGIOGRÁFICO IMAGER II - Registered in Anvisa under the number 10341350453 - 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
    1000
  • Date
    2010-01-08
  • 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 is aware that hospitals often remove the product from their outer carton and store it on the stock shelves only in their pouch. If this is a practice in your unit, it is very important that when searching for affected / collected product, you carefully use the enclosed product table, taking into account both the UPN code of the product in the inner and outer carton. Anvisa has no reports of adverse events or technical complaints regarding this problem to date. #### Update: Boston Scientific do Brasil Ltda informed the UTVIG / ANVISA about the closure of the field action related to this alert, on January 19, 2011. According to the company, 18 units of the product were collected from a total of 120 units under risk marketed in Brazil.
  • Reason
    Boston scientific has identified that for the affected products, the sterile closure of the pouch containing the catheter may be broken. the breach of sterility may lead to contamination of the device, with transfer of infectious agents to the patient. as of october 5, 2009, boston scientific has received three complaints in the united states reporting this problem with the packaging of the angiographic imager ii catheter. boston scientific is not aware of any complications to the patient resulting from this problem.
  • Action
    The Verification and Traceability Response Form included in this Voluntary Customer Grievance Notice must be completed and returned, even if you do not have any of the units for the voluntary recall codes and lots. 1. Immediately discontinue use and segregate all products from voluntary gathering. • Immediately remove all products from the affected voluntary recall of your inventory (either at the Radiology Department, Catheter Lab, Central Service, Shipment and Receipt or elsewhere). • Isolate this product in a safe area for return to Boston Scientific. 2. Complete and return the Verification and Traceability Response Form. • Complete the attached Verification and Traceability Response Form (even if you do not have a product to return) by following the instructions on this page and the Verification and Traceability Response Form. • Return the Verification and Traceability Response Form by fax to: Boston Scientific do Brasil Ltda. A / C: Dalton Nivoloni Fax: (11) 5502-8510 - e-mail: dalton.nivoloni@bsci.com Please fax your Form (s) for Verification and Traceability Response immediately. product, attach the original form. 3. Pack / ship the product of the Voluntary Retreat. • Pack the products to be returned in an appropriate box. • Identify the box with the customer's name. • Ask for the collection by calling (11) 5502-8583, with Danielle Almeida.

Device

CATEGORY ANGIOGRÁFICO IMAGER II - Registered in Anvisa under the number 10341350453 - Lots - see ...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA