MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. AUDION 6X20MM; EUSTACHIAN TUBE BALLOON DILATION SYSTEM

Model Number	AET-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
It was reported that after an audion eustachian tube dilation the patient sneezed/coughed forcibly and presented with a subcutaneous emphysema in the neck area.The patient was taken to the hospital for observation and kept overnight.No additional medical intervention was taken.

• Brand Name: AUDION 6X20MM
• Common Device Name: EUSTACHIAN TUBE BALLOON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: missty black ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15903802
• Report Number: 3006345872-2022-00010
• Device Sequence Number: 5775515
• Product Code: PNZ
• UDI-Device Identifier: 00850002250428
• UDI-Public: (01)00850002250428
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2022

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
• Device Model Number: AET-100
• Device Catalogue Number: AET-100
• Device Lot Number: A25240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown