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

Catalog Number	CFX-2000
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Codes	Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: d4 12 previously reported events are included in this follow-up record.Product return status 2 devices were received.6 devices were not available for evaluation.4 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 12 malfunction events in which the device reportedly had free or unrestricted flow.10 events had patient involvement: no patient impact.1 event required medication be provided.1 event had a cancelled/aborted surgical procedure.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 12 events were reported for this quarter.Product return status: 2 devices were received.6 devices were not available for evaluation.4 device investigation types have not yet been determined.Additional information: 12 devices were labeled for single-use.12 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 12 malfunction events in which the device reportedly had free or unrestricted flow.10 events had patient involvement: no patient impact.1 event required medication be provided.1 event had a cancelled/aborted surgical procedure.
Event or Problem Description
This report summarizes 11 malfunction events in which the device reportedly had free or unrestricted flow.7 events had patient involvement: no patient impact.1 event required medication be provided.2 events had a cancelled/aborted surgical procedure with no health consequences or impact.1 event had a cancelled/aborted surgical procedure with insufficient additional information provided.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h1, h6, h11 12 events were previously reported during the reporting quarter: however, 1 event was reported in error.11 previously reported events are included in this follow-up record.Product return status 5 devices were received.6 devices were not available for evaluation.

• Brand Name: CLARIFIX
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 21876292
• Report Number: 3006345872-2025-00005
• Device Sequence Number: 8769099
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: 00850002250404
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 11
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CFX-2000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 03/31/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/21/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown