MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LOPROFILE 6X20MM; INSTRUMENT, ENT MANUAL SURGICAL

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	08/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded by user facility.
Event or Problem Description
It was reported that a patient experienced a csf leak immediately following a multi-sinus balloon dilation procedure.The patient had surgery to patch the csf leak, was hospitalized for 2-3 days and then discharged.No further patient injury or complications have been reported.
Additional Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
Event or Problem Description
It was reported that a patient experienced a csf leak immediately following a multi-sinus balloon dilation procedure.The patient had surgery to patch the csf leak, was hospitalized for 2-3 days and then discharged.No further patient injury or complications have been reported.

• Brand Name: LOPROFILE 6X20MM
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• MDR Report Key: 10541645
• Report Number: 3006345872-2020-00006
• Device Sequence Number: 11373970
• Product Code: LRC
• UDI-Device Identifier: 00857326005017
• UDI-Public: 00857326005017
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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 Model Number: MSB&LLF
• Device Catalogue Number: LPLF-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2020
• Supplement Date Received by Manufacturer: 11/29/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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