Adverse Events Associated with Balloon Sinuplasty: A MAUDE Database Analysis

Area of Science:

• Otolaryngology
• Medical Device Safety
• Surgical Complications

Background:

• Balloon sinuplasty has seen increased utilization over the past decade.
• The most frequent complications associated with this procedure remain largely unknown.
• Understanding these adverse events is crucial for patient safety and procedural refinement.

Purpose of the Study:

• To analyze and categorize adverse events reported for balloon sinuplasty devices.
• To identify the most common patient-related and device-related complications.
• To inform healthcare providers about potential risks.

Main Methods:

• Retrospective cross-sectional analysis of data from the FDA MAUDE database (2008-2018).
• Searched for adverse events related to balloon sinuplasty devices from major manufacturers.
• Categorized reported events into patient-related, device-related, and packaging-related complications.

Main Results:

• 211 adverse events were reported, with 48.3% patient-related and 47.9% device-related.
• Most common device complications: guide catheter malfunction (39.6%), balloon malfunction (38.6%).
• Most common patient complications: cerebrospinal fluid leak (36.3%), eye swelling (29.4%).

Conclusions:

• Key complications include balloon/guide catheter malfunction, cerebrospinal fluid leaks, and significant eye swelling.
• Healthcare providers must counsel patients on these potential risks during the informed consent process.
• Further research may be needed to mitigate these identified adverse events.