MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5X16MM, F-70 GUIDE KIT; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number	RS0516F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hearing Loss (1882); Tinnitus (2103)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place in (b)(6) 2016.The lot number of the device is not available.Additional information will be submitted within 30 days of receipt.Product complaint # (b)(4).
Event or Problem Description
Acclarent was informed on 3/8/2018, of an event that took place in (b)(6) 2016, when the surgeon performed a eustachian tube dilation procedure using the relieva spin balloon sinuplasty system, 5x16mm, f-70 guide kit (rs0576f / lot# not available) off-label and the patient has hearing loss and tinnitus after the procedure.The symptoms have not improved over the past six months.There was no report of any malfunctions with the acclarent device used during the procedure.

• Brand Name: RELIEVA SPIN BALLOON SINUPLASTY SYSTEM, 5X16MM, F-70 GUIDE KIT
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• MDR Report Key: 7372136
• Report Number: 3005172759-2018-00106
• Device Sequence Number: 13464865
• Product Code: LRC
• UDI-Device Identifier: 10705031206304
• UDI-Public: 10705031206304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: RS0516F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability