MAUDE Adverse Event Report: ENTELLUS MEDICAL, INC. XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA; INSTRUMENT, ENT MANUAL SURGICAL

Model Number MSB&LLF

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

Patient Problem Epistaxis (4458)

Event Date 03/02/2023

Event Type  Injury  

Event Description

It was reported that during a sinus case with the xpress device the surgeon successfully ballooned both frontal and maxillary sinuses.The surgeon then ballooned the sphenoid sinus and upon pulling the balloon out of the sinus, the patient had an unusual amount of bleeding.The patient was treated with a nasal packing and embolization.

Manufacturer Narrative

Device discarded.

• Brand Name: XPRESS LOPROFILE ENT 6X20MM, FINAL PACKA
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer (Section G): ENTELLUS MEDICAL, INC.; 3600 holly lane north; suite 40; plymouth MN 55447
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16645740
• MDR Text Key: 312344951
• Report Number: 3006345872-2023-00005
• 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: K163509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB&LLF
• Device Catalogue Number: LPLF-106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2023
• 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