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

Model Number MSB&LLF

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/15/2018

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 discarded after the procedure.However, the 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.(b)(4).

Event Description

It was reported that after a right frontal balloon dilation with an xpress balloon device and followed by a full fess of the frontal, sphenoid, maxillary and ethmoid sinuses with septoplasty and bilateral turbinate reduction a csf leak was noticed near the left frontal sinus.The csf leak was repaired with a patch using skin graft along with packing product.The patient was admitted overnight for observation and discharged home the following morning without further issues.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: 7850762
• MDR Text Key: 119367136
• Report Number: 3006345872-2018-00002
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00857326005017
• UDI-Public: 00857326005017
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MSB&LLF
• Device Catalogue Number: LPLF-106
• Device Lot Number: A15245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2018
• 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): Required Intervention
• Patient Age: 60 YR