Events

Safety Alert for Rapid Exchange Dilatation Balloon Catheter

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc.

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
    R1707-313
  • Event Number
    2014DM-0012302
  • Date
    2017-07-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=77
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The importer has identified that in the referenced devices it may be difficult to remove the stylet, in such case, there is a possibility that the balloon or the catheter could be damaged due to the application of excessive force, so that it could be difficult to inflate or deflate the balloon, leading to possible adverse events on the patient or delays in the procedures.

Device

Rapid Exchange Dilatation Balloon Catheter
  • Model / Serial
    Euphora and Solarice, lots 212553130 to 213283557.
  • Product Description
    The dilatation balloon catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in order to improve myocardial perfusion. The dilatation balloon catheter is also indicated for post-deployment expansion of expandable balloon stents.
  • Manufacturer
    Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc

Manufacturer

Medtronic Ireland || Medtronic Mexico, S. De R. L. De C. V. || Medtronic Inc
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA