Materials and Methods
We used the Food and Drug Administration (FDA) Manufacturer And User Facility Device Experience (MAUDE) database, which lists reports from manufacturers, distributors, clinicians, and other voluntary reporters and is publicly accessible.3 We filtered the MAUDE data by device and adverse event type, examining ‘malfunction’, ‘injury’, and ‘death’ reports with the filter ‘Cardiac Ablation Percutaneous Catheter’ for cardiac ablation percutaneous catheters; the filter ‘Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation’ for cardiac ablation percutaneous catheters for atrial fibrillation treatment; and the filter ‘Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter’ for cardiac ablation percutaneous catheters for atrial flutter treatment. Since the World Health Organization officially declared COVID-19 a pandemic on March 11th, 2020,4 we chose to record the number of reports given each week over the course of two years: March 2019-March 2020, and March 2020-March 2021. For clarity, March 2020-March 2021 will be herein called ‘pandemic data’ or 2020-21, and March 2019-March 2020 will be called ‘pre-pandemic data’ or 2019-20. We performed paired t-tests for the differences between weekly reported adverse event types for each event type.