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 Problems Low Blood Pressure/ Hypotension (1914); Epistaxis (4458)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not available.

Event Description

In (b)(6) of 2023 the patient underwent a bilateral cryotherapy procedure as well as a concomitant turbinate reduction-submucosal.Three weeks after the procedure the patient presented with a sphenopalatine artery bleed and was hypotensive upon arrival for follow-up.The bleed was treated with cauterization and no further medical intervention or adverse consequences have been reported.

• 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: 18021877
• MDR Text Key: 326739054
• Report Number: 3006345872-2023-00011
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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?: Yes
• Date Manufacturer Received: 09/29/2023
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female