MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. LOPROFILE 6X20MM; XPRESS ENT DILATION SYSTEM

Catalog Number LPLF-106

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

Patient Problems Death (1802); Tissue Damage (2104); Loss of consciousness (2418)

Event Date 02/07/2020

Event Type  Death  

Manufacturer Narrative

After the procedure the patient's roommate informed the physician that the patient had been feeling sick, was taking otc cold medications in the days prior to the procedure and felt lightheaded at times.It was discovered after the procedure that the patient had a urology procedure the day prior to the balloon procedure.It was reported that the physician does not feel the event was related to the device or balloon dilation procedure.The device was discarded after the procedure and the lot number was not provided/known.Therefore, no investigation of the device was completed.Device was discarded by user.

Event Description

It was reported that during a balloon dilation office procedure, bilateral frontal sinuses were treated without incident.Left sphenoid dilation was completed with two dilations.The health care provider turned to the right sphenoid and abnormal bleeding was observed when the patient coughed.The patient was packed then lost consciousness and vital signs dropped.The patient was hospitalized and on life support.While on life support the patient was declared brain dead.Physician stated the event is unrelated to the balloon procedure or device.

• Brand Name: LOPROFILE 6X20MM
• Type of Device: XPRESS ENT DILATION SYSTEM
• 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: karen peterson ; 3600 holly lane north; suite 40; plymouth, MN 55447 ; 7634637066
• MDR Report Key: 9788153
• MDR Text Key: 182016661
• Report Number: 3006345872-2020-00001
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 163509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LPLF-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• 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): Death
• Patient Age: 73 YR