Chairman of Radiology RWJBarnabas Community Medical Center, United States
Purpose: To compare the safety of microwave ablation (MWA) systems by reviewing the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database.
Materials and Methods: The MAUDE database was queried from January 1, 2014 to August 31, 2024 using a device classification of “system, ablation, microwave and accessories.” The type of device and specific adverse events (AEs) were recorded. Incomplete, unverified, and duplicate reports were excluded. The categorized data were analyzed using a pairwise chi-square test of independence with Bonferroni correction to assess differences in device and patient complication incidence among three MWA device producers: manufacturer A (Covidien), B (NeuWave), and C (AngioDynamics).
Results: A total of 1,068 medical device reports were analyzed. MWA devices produced by manufacturers A and B had a higher incidence of breakage or fracture compared to those by manufacturer C (p < 0.001). Additionally, tips of MWA devices from manufacturer A were also more likely to detach (p < 0.001) and to have a system temperature problem (p < 0.001). Manufacturers A and B also had significantly higher rates of foreign bodies in patients post-use compared to manufacturer C (p < 0.001). Furthermore, devices from manufacturer B were associated with an increased frequency of pneumothorax compared to those from manufacturers A and C (p < 0.001).
Conclusion: An analysis of the MAUDE database reveals that the self-reported complication rates associated with MWA devices from manufacturers A and B are significantly higher. These findings suggest that careful consideration for the manufacturer when selecting MWA devices may reduce the incidence of procedure complications and minimize unintentional side effects for patients.
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