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.