Events

Safety Alert for CUTTING BALLOON PERIPHERAL. Registration at ANVISA: 10341350358. Risk Class III - High Risk.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Interventional Technologies Europe 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
    871
  • Date
    2007-06-12
  • 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
    According to Boston Scientific do Brasil Ltda, the most important potential clinical effect related to balloon leakage would be a prolongation or delay in the clinical procedure, due to the need to change the balloon and also due to the possibility of the arterotome detachment or twisting of the balloon. balloon folds. For further information regarding the case, check complementary health alert No. 875.
  • Reason
    Possibility of the balloon having a leak at the distal tip or a fault exists to maintain the pressure thereof.
  • Action
    Boston Scientific do Brasil Ltda reported that it communicated all the customers involved, collected all the affected products (57 units collected from customers and 25 units from the own warehouse) and already sent the defective products to its Distribution Center in Kerkrade (Holland). The company sent to UTVIG / ANVISA supporting documentation of the sending of units of the product under suspicion and letter of communication, which contains the information that the company considers that the action of recall of the product in Brazil has already been finalized.

Device

CUTTING BALLOON PERIPHERAL. Registration at ANVISA: 10341350358. Risk Class III - High Risk.

Manufacturer

Interventional Technologies Europe Ltda
  • Source
    ANVSANVISA