MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. XPRESS ENT DILATION SYSTEM; SINUS BALLOON DILATION SYSTEM

Model Number MSB&LLF

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

Patient Problems Blood Loss (2597); No Code Available (3191)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

At the time of this report, no further patient injury or negative health related outcomes have been reported.The device was discarded after the procedure and the lot number was not provide/unknown.Therefore, no investigation of the device was completed.

Event Description

It was reported that a patient experienced uncontrollable bleeding.After the physician dilated bilateral frontal and left sphenoid sinuses, the patient experienced uncontrollable bleeding.The patient was transferred to a hospital where a catheter embolization procedure was completed.Post-embolization the patient had partial vision loss in left eye.Physician stated the vision loss is related to embolization, and not balloon dilation procedure.Patient was not on anticoagulants prior to procedure and had no known bleeding issues.Physician feels that patient had a dehiscence of sphenoid sinus/bone tissue prior to the balloon dilation procedure which was a contributing factor to bleeding during balloon dilation procedure.The patient was hospitalized for one (1) week and discharged home.No further patient injury or complications have been reported.

• Brand Name: XPRESS ENT DILATION SYSTEM
• Type of Device: SINUS BALLOON 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: 7896361
• MDR Text Key: 120965282
• Report Number: 3006345872-2018-00004
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152434
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB&LLF
• Device Catalogue Number: UNK_INE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/20/2018
• 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: 60 YR