MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS MULTI-SINUS DILATION TOOL; SINUS BALLOON DILATION SYSTEM

Model Number MSB

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

Patient Problems Arteriosclerosis (1722); Fluid Discharge (2686)

Event Date 04/17/2014

Event Type  Injury  

Event Description

Patient had a successful, uneventful 6 sinus balloon dilation with septoplasty procedure.1-2 hours post procedures and prior to discharge, patient experienced drainage of clear, pinkish fluid from his nose.Drainage stopped after 1 hour, and md returned to surgery center to evaluate for a possible csf leak.No clear fluid was present during surgery and md could not locate csf leak or source of drainage.Md noted bleeding from the middle turbinate and performed a middle turbinate reduction with ethmoidectomy.Patient was given oral antibiotics and steroids, and kept for two nights for observation.No further complications were noted and the patient was discharged to home.

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 report if required.The device in question was disposed of post procedure and therefore the root cause of the event could not be identified.

• Brand Name: XPRESS MULTI-SINUS DILATION TOOL
• Type of Device: SINUS BALLOON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL; plymouth MN 55447
• Manufacturer Contact: karen peterson ; 3600 holly lane north; suite 40; plymouth, MN 55447-0000 ; 7634637066
• MDR Report Key: 3835778
• MDR Text Key: 4502504
• Report Number: 3006345872-2014-00001
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2014

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 Expiration Date: 03/31/2015
• Device Model Number: MSB
• Device Catalogue Number: LPLF-106
• Device Lot Number: A4866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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: 64 YR