What types of procedures is the Bard Rotarex Atherectomy Catheter used for?

The Bard Rotarex Atherectomy Catheter is primarily used to remove plaque or thrombus from peripheral arteries, particularly in the legs. These procedures are commonly performed to treat peripheral artery disease (PAD), where narrowed or blocked vessels reduce blood flow to the limbs. The device is intended for use in both native peripheral arteries and native or artificial bypasses, including vessels reconstructed through surgery or grafting. It can also be used in patients with prior vascular implants or repairs, such as stent grafts or bypass surgeries. However, these conditions may increase procedural risks, as previously repaired vessels can present uneven surfaces, narrowing, or scar tissue that complicate catheter advancement. When navigating around or through these areas, there is a higher likelihood of mechanical stress on the device, which could contribute to malfunction or injury.

What makes some patients more at risk for complications?

Patients whose peripheral arteries are fitted with stents, grafts, or previous surgical modifications may be at increased risk for catheter malfunction. Additionally, those with calcified vessel segments—arteries hardened by mineral buildup—are more likely to experience device-related problems, as the catheter’s rotating components can snag or fracture under pressure.

What procedural factors may increase the risk of Bard Atherectomy Catheter failure or injury?

Several procedural factors can contribute to catheter malfunction, including how the device is handled during insertion and operation. One critical recommendation is to reduce catheter advancement when resistance is felt, as forcing the device through difficult anatomy can lead to stress fractures. Physicians are advised to monitor the catheter closely, especially during use in vessels with sharp curves or narrowing, as these areas can increase localized pressure on the device. Patients with certain anatomical characteristics—such as tortuous vessels or heavily calcified arteries—are at higher risk for complications. Maintaining continuous blood flow and observing continuous drainage during the procedure are essential to verify that the catheter is functioning properly and not blocked. When these signs are absent, the device may be overheating or failing internally. Imaging techniques like digital subtraction angiography and proper contrast injection are used to guide the procedure and detect early signs of malfunction. Failing to recognize these warning signs in real time has been identified as a contributing factor in multiple adverse events, including catheter breakage, vessel injury, and emergency interventions.

How does the design and function of the Bard Atherectomy Catheter contribute to device failure?

The Bard Rotarex Atherectomy Catheter relies on a rotating catheter head that houses a high-speed helix portion, which is designed to break up and remove plaque or thrombus from within arteries. However, this internal helix can fracture under stress, especially when the device encounters resistance or is used in sharply curved vessels. A fractured catheter shaft or one catheter head breaking off during use can lead to vessel damage, internal bleeding, or embolization. Bending or kinking during procedures—especially in anatomically challenging areas—can weaken structural components, particularly if a kink resistant sheath is not used. The device is controlled by a control unit, which may emit audible control unit alarms when abnormal function is detected, but failure to respond to these alarms may allow a malfunction to worsen. Catheter bend is a known risk factor, as even minor flexion can cause fatigue in the rotating parts over time. In some cases, thermal stress or lack of adequate blood flow may contribute to catheter overheating, further increasing the likelihood of helix fracture. These design-related failures have been central to reports of injuries and deaths, prompting the current FDA recall and legal investigation.

What injuries have been linked to Bard Rotarex Atherectomy Catheter malfunctions?

When the Bard Rotarex Atherectomy Catheter fails—often due to helix fracture, catheter shaft breakage, or overheating—patients may suffer serious, potentially life-threatening complications. These injuries typically occur during procedures to remove blockages in peripheral arteries, especially when the catheter is stressed by difficult anatomy or improper technique. In many reported cases, broken catheter components have lodged in blood vessels or migrated, requiring emergency surgery to retrieve them. Some patients have experienced long-term damage or death as a result of these malfunctions. The most commonly reported complications include: <ul> <li>Severe internal bleeding from vessel injury</li> <li>Perforation or tearing of arterial walls</li> <li>Embolism caused by migrating catheter fragments</li> <li>Emergency surgery requiring retrieval of broken parts</li> <li>Infection or other adverse reactions from delayed treatment</li> <li>Death in extreme cases, particularly when the break went undetected during the procedure</li> </ul> These outcomes have prompted a growing number of lawsuits and triggered a Class I recall by the FDA.

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