MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. CLARIFIX; CRYOSURGICAL UNIT AND ACCESSORIES

Catalog Number	CFX-2000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Epistaxis (4458)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded after procedure.
Event or Problem Description
It was reported that four weeks after a bilateral septo turb procedure with cryotherapy the patient experienced epistaxis.The patient wore doyle splints for 5 days and then the doctor took the patient into surgery and cauterized the bleed.No additional epistaxis has occurred and no permanent damage was reported.
Additional Manufacturer Narrative
Section d4; gtin number updated.
Event or Problem Description
It was reported that four weeks after a bilateral septo turb procedure with cryotherapy the patient experienced epistaxis.The patient wore doyle splints for 5 days and then the doctor took the patient into surgery and cauterized the bleed.No additional epistaxis has occurred and no permanent damage was reported.

• Brand Name: CLARIFIX
• Common Device Name: CRYOSURGICAL UNIT AND ACCESSORIES
• 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; suite 40; portage, MI 49002 ; 2693237700
• MDR Report Key: 15591362
• Report Number: 3006345872-2022-00008
• Device Sequence Number: 14022766
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: 00850002250404
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/19/2023

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
• Device Catalogue Number: CFX-2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 09/19/2023
• 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