MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. XPRESS ULTRA ENT DILATION SYSTEM; SINUS BALLON DILATION SYSTEM

Model Number	MSB&LLF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Date of Event	11/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, no further patient injury or negative health related outcomes have been reported.The device was discarded after the procedure and the lot number was not provided.Therefore, no investigation of the device was completed.Device was discarded by user.
Event or Problem Description
It was reported that a patient experienced subcutaneous emphysema in the head, neck, and chest.After the physician successfully completed bilateral eustachian tube dilation, the patient was discharged home.On postoperative day 1, the patient reported sneezing vigorously while lifting 30 to 40 lbs at work and subsequently developing bilateral facial and neck swelling.The patient had a cat scan and was found to have subcutaneous emphysema of the head, neck, and chest with significant pneumomediastinum.Patient was put on sinus precautions (no nose blowing, lifting >5 lbs, drinking through straws, coughing, or sneezing with mouth closed).The patient's subcutaneous emphysema improved over 48 hours without intervention, and the patient was discharged home.No further patient injury or complications have been reported.

• Brand Name: XPRESS ULTRA ENT DILATION SYSTEM
• Common Device Name: SINUS BALLON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• MDR Report Key: 7851535
• Report Number: 3006345872-2018-00003
• Device Sequence Number: 1171494
• Product Code: PNZ
• UDI-Device Identifier: 00857326005123
• UDI-Public: 00857326005123
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K163509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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: No Information
• Device Model Number: MSB&LLF
• Device Catalogue Number: ULF-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR