MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. XPRESS LOPROFILE MULTI-SINUS 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 12/15/2016

Event Type  Injury  

Manufacturer Narrative

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

Balloon device was used in a case where a csf leak was noted, possibly due to entry into the skull base.Physician plugged the gap and the patient is doing well and happy with outcomes.Physician feels there was erosion that was likely present prior to the case.Physician believes the event is not related to balloon device and has not provided any additional details regarding the patient or the case.

• Brand Name: XPRESS LOPROFILE MULTI-SINUS DILATION SYSTEM
• Type of Device: SINUS BALLOON DILATION SYSTEM
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly ln n; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 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: 6232603
• MDR Text Key: 64167054
• Report Number: 3006345872-2017-00001
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K152434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2016

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: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: MSB
• Device Catalogue Number: LPLF-106-I
• Device Lot Number: A11217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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