Dive Brief:

• The Food and Drug Administration published an early alert on Thursday about a BD device linked to 30 serious injuries and four deaths.
• The FDA issued the alert one day after BD wrote to customers to recommend actions to mitigate the risks posed by a system used to break up and remove clots from arteries. 
• Stress, wear, high temperatures, friction or localized pressure can cause part of BD’s Rotarex device to break, the FDA said, and result in vessel injuries and severe bleeding.

Dive Insight:

Rotarex features a rotating catheter head and helix. The FDA has cleared the device for breaking up clots in native arterial vessels and in peripheral arteries fitted with stents, stent grafts and native or artificial bypasses. In September, BD wrote to the FDA to update the instructions for use to clarify and emphasize details that could reduce the risk of helix breaks and other “catheter breakage events.”

The update was triggered by evidence that parts of the Rotarex system can fracture or break. BD has reported 115 cases requiring additional intervention after helix fracture or breakage. Surgeons may need to remove broken catheters and device fragments.

BD has found breaks and fractures are associated with certain anatomical characteristics and procedural factors. The findings have informed the company’s updated recommendations, which include a call to use a kink resistant, suitably reinforced sheath, maintain adequate blood flow through the catheter and monitor the device closely for resistance to movement. 

BD is continuing to look into the causes of fractures and breaks. The FDA is also still reviewing information about the potentially high-risk device issue and will provide updates as significant new details become available. 

In the past, the FDA often shared information about safety problems months after companies wrote to customers. The creation of the early alert pilot project has led the agency to intervene earlier to spread the message about potentially high-risk device issues.

The FDA signed off on BD’s updated Rotarex instructions for use on Jan. 30. Six days later, BD sent a medical device correction letter asking customers to review the updated instructions and online training.

Rotarex is part of BD’s interventional business, a unit that management is looking to drive growth after the separation of its life science business. CFO Christopher DelOrefice named increased Rotarex market penetration as a contributor to double-digit quarterly growth at BD’s peripheral vascular disease business in May.