MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS LOPROFILE 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	03/16/2018
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.Entellus medical will continue to monitor this situation and provide subsequent reports if required.The device was discarded after the procedure and the lot number was not provided.Therefore, no investigation of the device was completed.
Event or Problem Description
It was reported that a patient experienced subcutaneous emphysema of the lower face.After the physician successfully completed a left side eustachian tube dilation, the patient was discharged home.Two (2) days later the patient experienced left sided facial swelling/inflammation and was examined by her physician.The patient had a cat scan and was found to have subcutaneous emphysema of the lower face.The patient was given a prescription of cipro and prednisone and was sent home.The patient is doing well with no further complications.

• Brand Name: XPRESS LOPROFILE ENT DILATION SYSTEM
• Common Device Name: SINUS BALLON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL; 3600 holly ln n; plymouth MN 55447
• MDR Report Key: 7426517
• Report Number: 3006345872-2018-00001
• Device Sequence Number: 16573141
• Product Code: PNZ
• UDI-Device Identifier: 00857326005017
• UDI-Public: 00857326005017
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K163509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: LPLF-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/12/2018
• 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: 53 YR