Analysis of Lacrimal Stents and Balloon Catheters Complications: A 10-Year Review of the FDA MAUDE Database.

PURPOSE

To analyze adverse events and failures associated with lacrimal stents, intubation sets, and balloon catheters using reports from the Food and Drug Administration's Manufacturer and User Facility Device Experience database over a decade.

METHODS

A retrospective analysis was conducted on 86 medical device reports from the Manufacturer and User Facility Device Experience database between May 27, 2014 and February 24, 2024. Data on adverse events, device types, and patient demographics were extracted. Descriptive statistics summarized the frequency and types of events.

RESULTS

A total of 86 device-related and 46 patient-related adverse events were reported. Among the patient-related events, 43 involved foreign body retention, 2 involved bloody tears, and one of slight bleeding. Regarding device-related events, 73.3% were tube-related, with the most common issues being tube penetration due to a missing stainless-steel ring (38.4%), followed by tube tip breakage (8.1%) and leaks (7%). Issues with the dilation process comprised 5.8%. Balloon-related problems, primarily balloon tears (10.5%), accounted for 20.9% of device-related events. The reports revealed demographic gaps, with complete patient information available in less than half of the cases. The findings highlight recurrent failure modes linked to specific device brands and insertion techniques.

CONCLUSION

This study offers a comprehensive overview of failure scenarios and associated risk factors for lacrimal stents, intubation sets, and balloon catheters. Detailing adverse events and device-specific issues, it aims to assist clinicians in anticipating potential complications and improving management strategies. Enhanced reporting and rigorous postmarket surveillance are crucial to further optimize device safety and effectiveness.