MAUDE Adverse Event Report: ENTELLUS MEDICAL XPRESS LOPROFILE 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 09/26/2017

Event Type  Injury  

Manufacturer Narrative

The device was discarded after the procedure.Therefore, no investigation of the device was completed.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.

Event Description

It was reported that after a bilateral frontal and sphenoid sinus dilation procedure with inferior turbinate reduction, the patient experienced a csf leak.The physician noted a csf leak following the sphenoid balloon dilation.The physician successfully repaired the leak with dural matirx and nasoseptal flap.The patient was hospitalized for one (1) week following the procedure and discharged home.No further patient injury or complications have been reported.

• Brand Name: XPRESS LOPROFILE ENT DILATION SYSTEM
• Type of Device: SINUS BALLOON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL; 3600 holly ln n, suite 40; 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: 6957702
• MDR Text Key: 89581592
• Report Number: 3006345872-2017-00003
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• 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: LPLF-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 77 YR