FDA shares warning about stroke prevention device after injury
The U.S. Food and Drug Administration (FDA) has issued a new warning about certain Boston Scientific catheters that should be removed from the market and returned to the manufacturer. These devices have been associated with an ongoing safety issue that resulted in at least one serious injury.
The new alert covers specific lots of the Enroute Transcarotid Neuroprotection System and Enroute Transcarotid Neuroprotection System Plus, two devices used by vascular surgeons and interventional cardiologists to perform transcarotid artery revascularization procedures. The Enroute system delivers transcarotid vascular access to clinicians and reduces the risk of stroke for patients presenting with carotid artery disease. It reverses blood flow in a way that keeps embolic debris away from the brain, providing clinicians with a minimally invasive alternative to carotid endarterectomy.
This warning was put in place after Boston Scientific identified a risk of arterial sheath tip separation or partial tip separation during use.
“Tip separation may require endovascular or surgical retrieval of the retained tip,” according to the FDA advisory. “Complications associated with a retained tip include embolism, stroke, transient ischemic attack, restenosis, or thrombosis.”
As of July 9, the FDA noted, one serious injury has been linked to this issue.
Image courtesy of Boston Scientific.
What customers should do
Customers should stop using these devices immediately and start the process of returning them to Boston Scientific. If customers know of any Enroute systems forwarded from one facility to the next, they should communicate with that facility about this concern right away.
Safety issue is still under investigation
This early alert is part of an FDA pilot program designed to help the agency communicate substantial safety risks while issues are still under investigation. The FDA has not yet determined the severity of this recall.
Click here for additional details, including specific lot numbers.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.