Boston Scientific POLARx Balloon Catheter Use Instructions Updated After 4 Deaths: FDA

Outdated use instructions can cause cerebral air embolisms, stomach bleeding, intestinal bleeding, septic shock and death.

Federal regulators have issued updated safety guidelines for the use of POLARx and POLARx FIT cryoablation balloon catheters, following an unexpected rise in procedure-related injuries.

The U.S. Food and Drug Administration (FDA) issued a Boston Scientific catheter correction on December 18, providing additional warnings and instructions to mitigate potential esophageal injury, which could lead to serious injuries, including atrio-esophageal (AE) fistula, which is a condition where the esophagus connects with the heart’s left atrium, potentially resulting in cerebral air embolism, stomach bleeding, intestinal bleeding, septic shock and death.

The Boston Scientific Cardiac Cryoablation System utilizes POLARx Cryoablation Balloon Catheters to treat recurrent symptomatic atrial fibrillation, a condition characterized by irregular and rapid heartbeats that can cause shortness of breath, dizziness, and chest discomfort.

Cryoablation is a minimally invasive procedure that uses freezing temperatures to target and destroy abnormal tissues responsible for these symptoms, offering an effective solution for patients whose symptoms do not respond to medication while preserving the surrounding healthy tissue.

Officials warned the recalled Boston Scientific products have already been associated with at least seven injuries and four deaths as a result of complications related to the outdated use instructions.

Boston Scientific first issued an Urgent Medical Device Advisory to all affected customers on October 10, which outlined the risk of atrio-esophageal fistula and provided recommendations to minimize this complication, noting that factors such as the location, frequency, and intensity of cryoablation applications may play a role.

This advisory also included updates to the “Warning” and “Procedure” sections, providing the following revised instructions:

• Monitor the location of the cryoballoon relative to the esophagus prior to delivering cryotherapy.
• Do not perform cryoablation directly over the esophagus or on the posterior wall of the left atrium to avoid the risk of freezing injuries to the esophagus.
• Avoid catheter manipulation that may deform the cryoballoon or displace the atrium toward the esophagus.
• Ablate cautiously if the balloon is placed close to the esophagus, ensuring the balloon temperature does not drop below -65°C, and avoid repeating ablations in the same location to minimize the potential for thermal accumulation.
• Use temperature monitoring with a probe placed in the esophagus and stop the ablation if the temperature decreases to 20°C.
• Use standard-of-care practices for verifying balloon positions, esophageal monitoring and phrenic nerve monitoring.
• Use the minimum number of cryoablation applications necessary to achieve pulmonary vein isolation and avoid repeating ablations in the same location.

The affected products include POLARx Cryoablation System, POLARx and POLARx FIT Cryoablation Catheters, and SMARTFREEZE Cryo-Consoles of the following models: CRBS POLARX FIT BALLOON CATHETER ST, ST 28MM OUS, and ST OUS models, and CRBS POLARX FIT BALLOON CATHETER LT, LT 28MM OUS, and LT OUS models.

For more information, consumers can contact Boston Scientific at 1-888-272-1001, by email at https://www.bostonscientific.com/en-US/contact-us-email2.html or visit the Heart Rhythm Society.

Adverse reactions or quality problems can also be reported to the FDA’s safety information and adverse event reporting program, MedWatch.