The Food and Drug Administration (FDA) has issued a critical early alert regarding a medical device manufactured by BD, following reports of serious injuries and fatalities. The device in question, Rotarex, is designed to disintegrate and remove clots from arteries but has been associated with 30 severe injuries and four deaths. The FDA's prompt action came after BD advised customers on mitigating the risks posed by potential failures in the system. Factors such as stress, wear, high temperatures, friction, or localized pressure can lead to part of the device breaking off, causing vessel injuries and significant bleeding.

Understanding the Risks and Mitigation Strategies

The Rotarex device utilizes a rotating catheter head and helix mechanism, which has received FDA clearance for breaking up clots in various arterial vessels. In September, BD updated its instructions for use to highlight preventive measures against helix fractures and other catheter breakage events. These updates were prompted by evidence that parts of the Rotarex system could fracture or break, necessitating additional interventions in 115 reported cases. Surgeons may need to extract broken catheters and device fragments during these incidents.

BD has identified that certain anatomical characteristics and procedural factors contribute to breaks and fractures. Consequently, the company has revised its recommendations to include using kink-resistant, reinforced sheaths, maintaining adequate blood flow through the catheter, and closely monitoring the device for movement resistance. BD continues to investigate the root causes of these issues, while the FDA remains engaged in reviewing information about this potentially high-risk device problem. The agency will provide updates as new details emerge.

Regulatory and Market Implications

The FDA's early alert initiative aims to expedite communication about potentially high-risk device issues, marking a shift from previous practices where information was shared months after companies notified customers. This proactive approach ensures that healthcare providers are promptly informed about safety concerns. On January 30, the FDA approved BD’s updated Rotarex instructions for use, followed by BD issuing a medical device correction letter six days later, urging customers to review the updated guidelines and complete online training.

Rotarex plays a crucial role in BD’s interventional business unit, which management aims to expand post-separation of its life science division. CFO Christopher DelOrefice highlighted increased Rotarex market penetration as a key driver of double-digit quarterly growth in BD’s peripheral vascular disease business in May. The ongoing investigation into device failures underscores the importance of continuous improvement and safety measures in medical technology.