MAUDE Adverse Event Report: ACCLARENT, INC. ACCLARENT AERA; EUSTACHIAN TUBE BALLOON DILATION DEVICE

Model Number	EU061655
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was preparing the acclarent aera eustachian tube balloon catheter on the sterile back table to be sure device was functional.The staff and surgeon noted the balloon catheter was bent and the balloon ruptured when the surgeon began to fill the balloon.Company was notified immediately after the case about the defect.Manufacturer response: for eustachian tube balloon dilation device, acclarent aera (per site reporter) manufacturer was notified and send in a replacement device.Rep will pick up next time at our facility.

• Brand Name: ACCLARENT AERA
• Common Device Name: EUSTACHIAN TUBE BALLOON DILATION DEVICE
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology dr.; irvine CA 92618
• MDR Report Key: 6935196
• Report Number: 6935196
• Device Sequence Number: 16475072
• Product Code: PNZ
• UDI-Device Identifier: 10705031230880
• UDI-Public: (01)10705031230880
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2017
• Report Date (Section F): 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 05/04/2018
• Device Model Number: EU061655
• Device Catalogue Number: EU061655
• Device Lot Number: 160505B-PC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEVICE WAS ON THE STERILE BACK TABLE OF THE SURGIC; NO OTHER THERAPIES
• Patient Age: 38 YR
• Date Report Sent to FDA: 09/18/2017