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 Problem Cerebrospinal Fluid Leakage (1772)

Event Date 05/05/2014

Event Type  Injury  

Event Description

Patient underwent a hybrid balloon dilation procedure with functional endoscopic sinus surgery (fess).Dilation of bilateral frontal and maxillary sinuses completed successfully.Md then performed a bilateral ethmoidectomy using a non-entellus microdebrider, after which clear fluid was noted near the right posterior side nearing the frontal sinus.A csf leak was confirmed and patient was treated with steroids in operating room.Patient was discharged the same day of procedure, placed on bed rest for 48 hours, and given oral antibiotics.No further complications were noted and the patient is doing well.

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 disposed of post procedure and therefore the root cause for the event could not be identified.However, md stated that the csf leak was too posterior to be caused by balloon dilation procedure or device, and felt that it was related to the microdebrider and ethmoid procedure.

• 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 ; 7634637066
• MDR Report Key: 3862843
• MDR Text Key: 20712963
• Report Number: 3006345872-2014-00002
• 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: 05/22/2014

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 Model Number: MSB
• Device Catalogue Number: LPLF-106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/22/2014
• 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: 42 YR