MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS ULTRA ENT DILATION SYSTEM; SINUS BALLOON DILATION SYSTEM

Model Number MSB

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

At the time of this report, no further patient injury or negative health related outcomes have been reported.Entellus medical will continue to monitor this situation and provide subsequent reports if required.The device was returned and device history records were reviewed.All manufacturing and quality assurance testing was carried out in accordance with standard procedure, and the device met specification at the time of release.In addition, further testing was conducted on the returned device and all performance specifications were met and no device failure was detected.

Event Description

It was reported that after multiple predilations of the left frontal sinus with the xpress balloon device, the physician noted clear fluid with slight bloody tint oozing from the patient's nose.On exam, the physician felt this was a csf leak.After the procedure the patient was discharged home with no additional complications and was scheduled to have a mucosal flap to repair the csf leak.Two (2) days later, the csf leak was successfully repaired.The patient was discharged home the next day.No further patient injury or complications have been reported.

• Brand Name: XPRESS ULTRA ENT DILATION SYSTEM
• Type of Device: SINUS BALLOON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL; 3600 holly ln n; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL; 3600 holly ln n, suite 40; plymouth MN 55447
• Manufacturer Contact: karen peterson ; 3600 holly ln n, suite 40; plymouth, MN 55447 ; 7634637066
• MDR Report Key: 7134407
• MDR Text Key: 95365839
• Report Number: 3006345872-2017-00004
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MSB
• Device Catalogue Number: ULF-106
• Device Lot Number: A13889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2017
• 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: 69 YR