Reports & Research
Quarterly signal intelligence reports, academic research, and analysis covering cardiac device safety trends from FDA MAUDE data.
Quarterly Reports
Each quarter, we analyze FDA MAUDE adverse event data across 32 cardiac device categories using 6 statistical detection methods. Reports cover signal spikes, emerging trends, category comparisons, and failure mode clustering.
Publications
Data Quality of Device Identification in FDA MAUDE Reports for Cardiovascular Devices
Matthew W. Segar, Kaleb D. Lambeth, Shyon Parsa, Kavya Sinha, Mehdi Razavi
Of 942,414 cardiovascular MAUDE reports across 32 product codes, 93.4% matched a GUDID device entry, but a quarter matched only on fuzzy brand name. Brand-level matches were right about 84% of the time and rarely identified the specific model. UDI-DI reporting rose from 52% in 2019 to 83% in 2026.
Read the paper
Adverse Event Landscape of Pulsed Field Ablation Catheters: A Computational Review of FDA MAUDE Post-Market Surveillance Data
Matthew W. Segar, Kaleb D. Lambeth, Shyon Parsa, Mehdi Razavi
A keyword-based NLP pipeline applied to 6,930 MAUDE reports across all four FDA-cleared pulsed field ablation systems. PFA-specific physiologic events (coronary spasm/STEMI, hemolysis/AKI, phrenic nerve palsy) formed a safety phenotype distinct from device malfunction.
Read the paperThis system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification.