Alert Issued on Conavi’s Novasight Catheters

An FDA alert says Conavi has sent an “Urgent Medical Device Product Removal” notice to customers about removing certain Novasight hybrid catheters from the market. The action is based on one reported incident involving the device’s sheath detaching from the catheter during use and was left in the patient’s body, according to the alert. The full sheath was able to be removed from the patient’s body without further injury, it says.

“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,” the alert says. “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.”