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

Catalog Number RS0516F

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

Patient Problems Hearing Loss (1882); Tinnitus (2103)

Event Type  Injury  

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 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
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer (Section G): ACCLARENT, INC.; 33 technology drive; irvine 92618
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine 92618 ; 949789-868
• MDR Report Key: 7372136
• MDR Text Key: 103515242
• Report Number: 3005172759-2018-00106
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031206304
• UDI-Public: 10705031206304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RS0516F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• 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): Disability