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

Catalog Number	CFX-2000
Medical Device Problem Codes	Free or Unrestricted Flow (2945); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cryogen delivery at the user facility the device could not be shut off, potentially exposing the patient to excessive cryogen delivery.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Update: d4, d9, h3, h6 device evaluation: follow-up report submitted to document the device evaluation.
Event or Problem Description
It was reported that during cryogen delivery at the user facility the device could not be shut off, potentially exposing the patient to excessive cryogen delivery.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19522227
• Report Number: 3006345872-2024-00006
• Device Sequence Number: 8540418
• Product Code: GEH
• UDI-Device Identifier: 00850002250404
• UDI-Public: (01)00850002250404(21)250701(10)23212193
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K190356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CFX-2000
• Device Lot Number: 23212193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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