NYMC Faculty Publications


Device-Related Adverse Events During Percutaneous Nephrolithotomy: Review of the Manufacturer and User Facility Device Experience (MAUDE) Database

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INTRODUCTION AND OBJECTIVES: Percutaneous Nephrolithotomy (PCNL) is an established technique for removal of large stones from the upper urinary tract. It is a complex, multistep procedure requiring several classes of instruments that are subject to operator misuse and device malfunction. We report device-related adverse events during PCNL from the MAUDE database using a recently developed standardized classification system. METHODS: The MAUDE database was queried for "percutaneous nephrolithotomy" from 2006 to 2016. The circumstances and patient complications associated with classes of devices used during PCNL were identified. We then utilized a novel MAUDE classification system to categorize clinical events. Logistic regression analysis was performed to identify associations between device classes and severe adverse events. RESULTS: A total of 218 device-related events were reported. The most common classes included: lithotripter 53 (24.3%), wires 43 (19.7%), balloon dilators 30 (13.8%) and occlusion balloons 28 (12.8%). Reported patient complications included need for a second procedure 12 (28.6%), bleeding 8 (19.0%), retained fragments 7 (16.7%), prolonged procedure 4 (9.5%), ureteral injury 2 (4.8%) and conversion to an open procedure 3 (7.1%). Using a MAUDE classification system, 176 complications (81%) were Level I (mild/none), 26 (12%) were Level II (moderate), 15 (7%) were Level III (severe) and 1 (0.5%) was Level IV (life threatening). On univariate analysis, balloon dilators had the highest risk of Level II-IV complications compared to the other device classes [OR: 4.33, CI: 1.978-9.493, p<0.001]. The device was evaluated by the manufacturer in 93 (42.7%) cases, with 54.8% of reviewed cases listing the source of malfunction as misuse by the operator. CONCLUSIONS: PCNL is subject to a wide range of device-related adverse events. A MAUDE classification system is useful for standardized, clinically-relevant reporting of events. Our findings highlight the importance of proper surgeon training with devices to maximize efficiency and decrease harm.