Events

Recall of FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01290-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01290-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Medtronic is advising of an update to the medtronic flexcath advance steerable sheath, instructions for use (ifu). this ifu revision incorporates current best practices for minimising the potential for air ingress and the risk of air embolism.The ifu update includes additional language emphasising minimisation of catheter exchanges, proper aspiration and flushing techniques, and slow advancement and withdrawal of catheters through the sheath.There are no changes to the management of patients who have been or will be ablated with a system using a flexcath advance steerable sheath. it continues to perform as expected in relation to the potential for haemostatic valve leak. this failure mode is monitored and the occurrence rate has been stable over time. as of 31-august-2017, 79 reports of adverse events have been reported out of more than 255,800 devices distributed worldwide. one catastrophic event, associated with death, may have been related to this issue.
  • Action
    Medtronic is providing users with a supplement 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.

Device

FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Cathet...
  • Model / Serial
    FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve)Model Number: 4FC12All Lot NumbersARTG Number: 213965
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA