MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA; 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	Epistaxis (4458)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a sinus case with the xpress device the surgeon successfully ballooned both frontal and maxillary sinuses.The surgeon then ballooned the sphenoid sinus and upon pulling the balloon out of the sinus, the patient had an unusual amount of bleeding.The patient was treated with a nasal packing and embolization.
Additional Manufacturer Narrative
Device discarded.

• Brand Name: XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16645740
• Report Number: 3006345872-2023-00005
• Device Sequence Number: 5491222
• Product Code: LRC
• UDI-Device Identifier: 00857326005017
• UDI-Public: 00857326005017
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown