FDA Warns of Dangerous Rotarex Atherectomy Device Failures:

The U.S. Food and Drug Administration (FDA) has issued a warning regarding serious safety concerns with rotarex atherectomy devices manufactured by Bard Peripheral Vascular, a subsidiary of Becton, Dickinson, and Company (BD). These medical devices, used to remove plaques and blood clots from peripheral arteries, have been found to break during use, leading to severe injuries and even death. If you or a loved one has suffered complications from a defective medical device, KBA Attorneys is here to help.

Understanding the Issue

Atherectomy devices are essential tools for treating blocked arteries by removing plaque buildup and restoring blood flow. The Bard Peripheral Vascular Rotarex Atherectomy System, in particular, operates by spinning a rotating helix at high speed to cut through obstructions. However, the FDA has found that these devices may fracture or break due to stress, wear, high temperatures, friction, or pressure during use. This malfunction can lead to severe complications, including:

• Vessel injury
• Severe bleeding
• The need for emergency surgery to remove broken device fragments
• Death

The FDA has reported over 100 incidents linked to these devices, including 30 serious injuries and four deaths. This alarming trend highlights the urgent need for patients and healthcare providers to be aware of the risks associated with this medical equipment.

Manufacturer’s Response and Updated Guidelines

In response to the safety concerns, Bard Peripheral Vascular and BD have updated their Instructions for Use (IFU) for these devices. Key changes include:

• Use of a reinforced sheath: Cardiologists are now advised to use a kink-resistant sheath that is either the same size or one size larger than the Rotarex Atherectomy System.
• Avoiding use in certain conditions: The device should not be used in arteries with a curvature of less than 4 cm in diameter or across vessel bifurcations.
• Maintaining adequate blood flow: Keeping blood flow at optimal levels can reduce the risk of the catheter overheating or becoming blocked.
• Constant catheter movement: Physicians are instructed to perform a smooth back-and-forth motion within the affected artery to minimize stress on the device.
• Avoidance of heavily calcified arteries: The device should not be used in vessel segments with calcifications longer than 10 mm.
• Monitoring resistance: Doctors should slow catheter advancement or flush the catheter to prevent breakage if there is resistance.

These recommendations aim to reduce the likelihood of device failure, but they do not eliminate the risks entirely. Patients and healthcare providers should remain vigilant and consider alternative treatment options when possible.

FDA’s Position on the Issue

As of now, the FDA has not officially classified this as a recall. However, it has issued an early alert to inform healthcare providers and patients about the potential dangers. The agency is still evaluating the severity of the problem and will provide further updates as new information becomes available. This alert is part of the FDA’s pilot program to improve transparency and ensure public awareness of high-risk medical device issues.

What This Means for Patients

If you or a loved one has undergone an atherectomy procedure using a Bard Peripheral Vascular device, it is crucial to:

1. Monitor for symptoms: Be aware of signs of complications such as unusual pain, excessive bleeding, dizziness, or difficulty breathing.
2. Consult your doctor: If you have concerns about a past procedure, speak with your healthcare provider to discuss potential risks and necessary follow-ups.
3. Stay informed: Keep up with FDA updates and manufacturer announcements regarding these devices.

How KBA Attorneys Can Help

At KBA Attorneys, we specialize in handling cases related to defective medical devices. We have extensive experience advocating for patients who have suffered injuries due to unsafe medical products. We stay committed to holding manufacturers accountable for their negligence. If you or a loved one has been affected by a defective atherectomy device, you may be entitled to compensation for:

• Medical expenses
• Lost wages
• Pain and suffering
• Wrongful death claims (for families who have lost a loved one)

Why Choose KBA Attorneys?

• Expertise in medical device litigation: We have a proven track record of successfully representing clients in complex cases involving defective medical devices.
• Commitment to justice: We have a dedication in ensuring that companies prioritize patient safety over profits.
• Personalized legal support: We work closely with our clients to understand their unique situations and provide the best possible legal guidance.

Next Steps

If you believe the Bard Peripheral Vascular Rotarex Atherectomy System or any other defective medical device has affected you, do not wait to take action. Contact KBA Attorneys today for a free consultation. We will evaluate your case, explain your legal rights, and help you seek the justice and compensation you deserve.

Stay Updated

KBA Attorneys regularly monitors FDA warnings and medical device recalls to keep our clients informed. We will continue to research and post updates on this issue as new information emerges. For more details on medical device safety and legal options, visit our blog or reach out to our team.

Your health and safety matter. If a defective medical device has harmed you or a loved one, KBA Attorneys is here to fight for you.