MAUDE Adverse Event Report: ACCLARENT, INC. AERA; ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM

Catalog Number	EU061655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported by a physician that they were informed about a patient that was dilated in office on (b)(6) 2025, using an aera eustachian tube balloon dilation system (eu061655), that was headed to the emergency room due to subcutaneous emphysema.It was reported that no acclarent personnel was present during the procedure.The physician indicated that there was no malfunction of the device; "the procedure went well and the patient went home feeling well".It was subsequently reported that the patient was discharged from the er visit on (b)(6) 2025.According to the physician, the balloon was not inappropriately forced through a false passage during balloon placement.Additionally, there was no surgical delay.
Additional Manufacturer Narrative
Updated fields: d9, g3, g4 (pma/510(k) #), g6, h2, h3, h6, h11.Additional information: b5: it was reported that the subcutaneous emphysema was self-limiting and was resolved.The reporter advised that the aera eustachian tube balloon dilation system (eu061655) was not available for return; therefore, an evaluation of the device could not be performed.Additionally, no device defect or malfunction was identified in the complaint report.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: AERA
• Common Device Name: ACCLARENT AERA EUSTACHIAN TUBE BALLOON DILATION SYSTEM
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; 31 technology drive; CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine; CA 92618
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22367377
• Report Number: 3003418325-2025-00030
• Device Sequence Number: 15433548
• Product Code: PGW
• UDI-Device Identifier: 10705031230880
• UDI-Public: 10705031230880
• Combination Product (Y/N): N
• PMA/510(K) Number: K230742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EU061655
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown