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Real-World Safety of Suction-Enabled Ureteroscopic Systems: Updated MAUDE Database Analysis (2024-2025)
Daniel Pohl, MD, BA, Kelly Crane, MD, William Faust, MD.
Lahey Clinic, Burlington, MA, USA.
BACKGROUND: Suction-enabled ureteroscopic systems, including CVAC and ClearPetra, are novel technologies designed to improve stone clearance. While these new products are promising, it is also necessary to remain vigilant of the unintended adverse events they may prompt. To that end, we evaluated post-market adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS: MAUDE reports from January 2024 to October 2025 were compiled for ureteroscopes and ureteral access sheaths (UAS). Each report was categorized by manufacturer and Clavien-Dindo (CD) grade. CD 0 represented device malfunction (broken/dirty) and CD ≥ 1 indicated patient harm. Clinically significant complications were defined as CD ≥ 3. Fisher's exact test compared suction-capable systems (e.g., CVAC, ClearPetra) to non-suction devices. Suspected reporting rates per 20,000 uses were estimated for each suction system, given CVAC has reported 20,000 uses in the study time period.
RESULTS: A total of 566 reports related to UAS and ureteroscopes were identified. CVAC accounted for 23 and ClearPetra for 1. Clinically significant (CD ≥ 3) complications occurred in 10 CVAC (43.5%) and 1 ClearPetra (100%) reports. The ClearPetra report and 7/10 of the CVAC reports were found to be due to device-related injury while 3/10 of the CVAC reports were found to be infectious. Assuming 20,000 uses each from Jan 2024-Oct 2025, the suspected MAUDE reporting rate for clinically significant events was 0.05 % for CVAC and 0.005 % for ClearPetra. Fisher's testing indicated higher odds of patient harm for suction devices compared to non-suction systems (p < 0.001).
CONCLUSIONS: Despite low suspected reporting rates per use, a disproportionate number of severe adverse events exist for certain ureteroscopic suction device systems. These findings constitute an early signal that some suction ureteral access systems pose a higher risk of adverse events than others and may need more investigation into real world pressure modulation design optimization.
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