Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis

OBJECTIVE: Tracheotomy is one of the most common procedures. Although tracheostomy complications have been extensively studied, literature related to device complications is scarce. The objective of this study is to describe complications associated with tracheostomies utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. STUDY DESIGN: Retrospective cross-sectional study. SETTING: The US Food and Drug Administration's (FDA) MAUDE database (2015-2020). METHODS: The FDA's MAUDE database was queried for all reports on adverse events related to tracheostomy from January 1, 2015 to December 31, 2020. RESULTS: A total of 3086 adverse events related to open tracheostomy and 52 related to percutaneous tracheostomy were identified. For open tracheostomy, 2872 (93%), were related to device malfunction, and 214 (7%) consisted of patient-related factors. The most frequently reported device-related adverse event was cuff malfunction, with 1834 (59%) reported events, which includes cuff deflation, pilot balloon malfunction, and cuff inflation line malfunction. The most frequently reported patient-related adverse events were tracheostomy tube obstruction with 67 events (2%). For percutaneous tracheostomy, 38 (73%) events were related to device malfunction, and 14 (27%) were related to patient injury. The most frequently reported adverse events were cuff malfunction (29%), safety ridge malfunction (17%), and bleeding (10%). CONCLUSION: The MAUDE database is a useful tool that can be utilized to complement existing literature in identifying common and rare adverse events associated with tracheostomy device-related failures, which are mostly reliant on isolated, published case reports.