Its communication comes as part of its pilot to enhance the medical device recall program. The FDA said it became aware of the issue after Conavi sent a letter to affected customers recommending the removal of certain catheters.
The communication relates to the Novasight Hybrid catheter (TA-06-0001). Affected lot numbers include 230902, 240202, 240302, 240402 and 240502.
Novasight Hybrid was designed for guiding common minimally invasive coronary procedures. The catheter combines both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) to enable simultaneous and co-registered imaging of coronary arteries.
Conavi warned on the system because of one reported incident in which the catheter detached during use. It was left in the patient’s body, but the full sheath was able to be removed from the patient without further injury.
Risks associated with removing a detached catheter sheath inside a coronary artery include coronary artery spasm, dissection, perforation, thrombosis, embolism and abrupt vessel closure. The removal process can lead to hemodynamic consequences, too. These include heart rhythm conduction disturbances (bradyarrhythmia and tachyarrhythmia), hypotension, and respiratory insufficiency. If retrieval fails, the patient may require emergent cardiac surgical intervention.
The company reports no additional incidents or injuries associated with the injury.
Conavi sent all affected healthcare providers an urgent medical device product removal notice last month. The company recommended that customers search inventory for affected products and return them to Conavi.
