Events

Safety Alert for FlexCath Advance Steerable Sheath

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Medtronic.

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
  • Date
    2017-10-12
  • Event Date Posted
    2017-10-12
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171012.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: medtronic flexcath advance steerable sheath medical device manufacturer, medtronic, has issued a medical device safety alert concerning its flexcath advance steerable sheath (model number 4fc12). the manufacturer is informing customers regarding an update to the abovementioned product’s instructions for use (ifu) manual. this ifu revision incorporates current best practices for minimizing the potential for air ingress and the risk of air embolism. this ifu update is not in response to a device design deficiency, device malfunction, or a change in reported field performance data. air embolism is a known risk for patients undergoing percutaneous interventions requiring access to the left atrium, such as ablation procedures. according to the 2017 hrs/ehra/ecas/aphrs/solaece expert consensus statement on catheter and surgical ablation of atrial fibrillation, “the most common cause of air embolism is introduction of air via the transseptal sheath.” the manufacturer has supplemented the flexcath advance steerable sheath ifu to highlight the known risk of air embolism more prominently. these updates do not impact current clinical practice as this information is consistent with current training and education materials, and with recommendations from hrs, jhrs, and ehra. users are advised to review the ifu update summary regarding air ingress and air embolism provided by the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 october 2017.

Device

FlexCath Advance Steerable Sheath
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic FLexCath Advance Steerable Sheath
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    DH