MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS LOPROFILE ENT DILATION SYSTEM; SINUS BALLOON DILATION SYSTEM

Model Number	MSB&LLF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	06/15/2018
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.However, the device history records were reviewed.All manufacturing and quality assurance testing was carried out in accordance with standard procedure, and the device met specification at the time of release.(b)(4).
Event or Problem Description
It was reported that after a right frontal balloon dilation with an xpress balloon device and followed by a full fess of the frontal, sphenoid, maxillary and ethmoid sinuses with septoplasty and bilateral turbinate reduction a csf leak was noticed near the left frontal sinus.The csf leak was repaired with a patch using skin graft along with packing product.The patient was admitted overnight for observation and discharged home the following morning without further issues.No further patient injury or complications have been reported.

• Brand Name: XPRESS LOPROFILE ENT DILATION SYSTEM
• Common Device Name: SINUS BALLOON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL; 3600 holly ln n, suite 40; plymouth MN 55447
• MDR Report Key: 7850762
• Report Number: 3006345872-2018-00002
• Device Sequence Number: 16436939
• Product Code: LRC
• UDI-Device Identifier: 00857326005017
• UDI-Public: 00857326005017
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152434
• 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): 07/10/2018

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: A15245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2018
• 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: 60 YR