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

Catalog Number CFX-2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Epistaxis (4458)

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that three weeks after a bilateral cryotherapy procedure the patient presented with epistaxis.The bleeding was treated with posterior nasal packing and the patient was advised to not take anticoagulant medication, the patient was kept overnight at the hospital and released with no further complications.

Manufacturer Narrative

H3 other text : device not available.

• Brand Name: CLARIFIX
• Type of Device: 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; portage, MI 49002 ; 2693237700
• MDR Report Key: 18181747
• MDR Text Key: 328637438
• Report Number: 3006345872-2023-00012
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CFX-2000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male