FDA warns that certain coronary imaging catheters are being removed from market over safety concerns
The U.S. Food and Drug Administration (FDA) is warning healthcare providers about a potential safety issue involving the catheters that go with Conavi Medical’s Novasight Hybrid System.
A recall has not been put in place at this time. However, certain lots of the catheters are being removed from the market as Conavi Medical and the FDA continue to monitor the situation.
The reason for the early safety alert
The Novasight Hybrid System is used for performing optical coherence tomography (OCT) and intravascular ultrasound (IVUS) of the coronary arteries. It is 149 cm long and features multiple radiopaque markers.
This early alert was put in place after a catheter sheath detached during use and was left in a patient’s body. The sheath was successfully removed without any further injuries.
“Risks associated with the removal of a detached catheter sheath inside a coronary artery include coronary artery spasm, dissection, perforation, thrombosis, embolism, and abrupt vessel closure,” according to the alert. “In addition, during the removal process there may be hemodynamic consequences such as heart rhythm conduction disturbances (bradyarrhythmia and tachyarrhythmia), hypotension, and respiratory insufficiency. If retrieval strategies fail, emergent cardiac surgical intervention may be required.”
Image courtesy of the FDA's early alert.
No additional incidents have been reported at this time.
Convavi Medical sent all affected healthcare providers an Urgent Medical Device Product Removal notice in March. It warned that all unused products impacted by this alert should be returned.
What’s next?
For now, the FDA is recommending that healthcare providers check back regularly with the agency’s website for further updates. If a full recall is announced, the FDA will provide an update.
“The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” according to the alert.
Lot numbers included in this alert were 230902, 240202, 240302, 240402, and 240502. Click here for additional information from the FDA.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.