Health Canada has issued a safety alert concerning Percutaneous Radiofrequency (RF)Ablation Catheter and the Potential Risk of Atrioesophageal Fistula (AEF).
The percutaneous ablation catheters are single use devices used for the treatment of symptomatic arrhythmia, most commonly atrial fibrillation (AF), which do not respond to drug therapies. They are designed to facilitate electrophysiological mapping, pacing of the heart chambers, and when used in conjunction with a compatible RF generator, to transmit RF energy to the cardiac tissues in order to block the erratic electrical signals.
When RF ablation catheters are used to treat AF, an AEF may develop as a result of esophageal injury due to the close anatomic relationship between the esophagus and the heart. AEF usually occurs within 1 to 6 weeks following an AF ablation procedure using these catheters. Early symptoms of AEF are usually non-specific and may include fever, chest pain, dyspnea, dysphagia, odynophagia, nausea, vomiting and hematemesis. Late presentation may involve altered mental status, seizures and coma secondary to endocarditis and septic emboli.
A diagnosis of AEF may not be considered in a timely fashion due to delayed and non-specific clinical presentation potentially occurring in the majority of cases. The risk is low, but AEF is associated with high mortality, reported as being between 67% and 100% of cases. Cases of AEF, including death associated with the use of percutaneous RF ablation catheters for the treatment of AF, have been reported internationally.
Healthcare professionals are advised to watch for early signs/symptoms of AEF in patients with a recent history of AF ablation. When AEF is suspected, prompt diagnosis and timely management may contribute to optimal patients' outcomes.
For details, please refer to the Health Canada websites:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/66492a-eng.php
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 April 2018.