MAUDE database and Eustachian tube balloon dilation: Evaluation of adverse events and sales data.

STUDY DESIGN

Review of database.

SETTING

Tertiary care neurotology center.

PATIENTS

Patients undergoing adverse events.

INTERVENTION

MAUDE database evaluation of Eustachian tube balloon dilation (ETBD) for the treatment of Eustachian tube dysfunction.

MAIN OUTCOME MEASURES

Medical device reports (MDRs) from the MAUDE database were analyzed for adverse patient events (AE) and device malfunctions (DM) among different devices for ETBD. The objective of this analysis is to assess AE rates and compare them across different devices. Sales data was also used to calculate AE rates.

RESULTS

There were 18 MDRs noted in the MAUDE database for patients undergoing ETBD out of an initial 23 results. When separated into devices, the Aera had 9 total MDRs (50 %), Xpress had 8 (44.4 %) and Audion had 1 (5.6 %). There were 10 AE and 8 DM. When separated by device, Aera had 4 AEs and 5 DMs, Xpress had 5 AEs and 3 DMs, and Audion had 1 AE. The most common AE was subcutaneous emphysema (n = 4), in the head and neck region with one report of mediastinal involvement. Using this sales data, the Aera balloon has an MDR rate of 0.0128 % is established, with a rate of AE at 0.0058 %. The Audion balloon had an MDR and AE rate of 0.0164 %.

CONCLUSIONS

ETBD is a safe procedure with minimal complications, with subcutaneous emphysema being the most commonly reported adverse event, consistent with literature findings. A comprehensive analysis of AE, coupled with sales data, indicates a commendably low MDR rate of 0.0128 % for the Aera balloon while the Audion balloon had an MDR rate of 0.0164 %. These findings offer valuable insights on post-procedure expectations and engaging in informed consent discussions with patients, highlighting the overall safety of ETBD as an intervention.