Introduction
Adverse event reporting is essential for post-market surveillance and risk assessment of medical devices, and can also serve as an indicator of overall care patterns and device utilization. We have previously communicated that the COVID-19 pandemic was associated with a significant 46% decrease in weekly reported deaths attributed to implantable cardioverter defibrillators (ICDs), and a significant 27% decrease in weekly reported injuries attributed to coronary drug-eluting stents.1 In addition, we have shown that the COVID-19 pandemic was associated with significant shifts in reported adverse events for valve replacement and repair, in particular a 27% decrease in weekly reported injuries attributed to non−allograft tissue heart valves.2 This report assesses the impact of the COVID-19 pandemic on the number of weekly reports of adverse events attributed to three FDA cardiovascular medical device classes: cardiac ablation percutaneous catheters; cardiac ablation percutaneous catheters for treatment of atrial fibrillation; and cardiac ablation percutaneous catheters for treatment of atrial flutter.