The FDA is getting the word out on a high-risk issue related to artery-clearing catheters from BD’s Bard Peripheral Vascular division.
According to the agency, BD has reported 30 serious injuries and four deaths linked to fractures or breaks within its Rotarex atherectomy systems—which includes a spinning tip to break through calcified blockages within the vessel, as well as a helix-shaped rotor that spans the inner length of the catheter to remove broken-off pieces of blood clots.
BD issued a medical device correction notice to healthcare providers February 5, urging users to review the system’s updated instructions and its online training programs. At this time no hardware needs to be returned to the company.
The FDA has not yet issued a formal recall classification; the agency’s early alert is part of a pilot program, launched late last year, to accelerate communications to the public about efforts to ensure device safety.
According to BD, certain patient anatomies—such as the angle, size and curve of their blood vessels—may make it more likely for the Rotarex catheters to break while in operation.
Specifically, the company told providers to not employ the system if the catheter needs to bend across a sharper arc that would be less than 4 centimeters in diameter, such as where the descending aorta splits into the two main arteries that feed the hips and legs.
Other factors may include the degree of calcification within the vessel’s segments, as seen under imaging, and the need to maintain smooth, constant movements of the catheter to reduce the stress on its components.
BD also recommended using a kink-resistant, reinforced sheath and to maintain adequate blood flow through the Rotarex catheter to reduce the risk of overheating.
In addition to the reported serious injuries, the company identified 115 cases that needed new interventions following fractures in the catheter’s helix rotor. The FDA said those breaks may require surgical retrieval of device fragments, and that they may cause vessel injuries resulting in severe bleeding. The agency said BD is continuing to investigate other contributing factors.