MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SCOUT® MULTI-SINUS DILATION SYSTEM 6X24MM (5 PK); INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number	SCT0624MFS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	12/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient identifier is not known.The patient¿s age / date of birth is not known.The patient's weight is not known.A review of the lot history record the subject device (lot# 160809a-pc) did not present any issues during the manufacturing or inspection process that can be related to the reported complaint.The acclarent products used during the procedure were said to have functioned as expected.No malfunctions were reported with any acclarent devices used during this procedure.No acclarent devices are available to be returned for evaluation as they were discarded by the user facility.Additional information will be submitted within 30 days of receipt.(b)(4).
Event or Problem Description
Acclarent was informed on (b)(6) 2017, of an event that occurred on (b)(6) 2017, involving a relieva scout® multi-sinus dilation system 6 x 24 mm (lot#: 160809a-pc).During a primary functional endoscopic sinus surgery (fess) procedure, the patient developed a cerebrospinal fluid (csf) leak after the first inflation at 12 atm in the right frontal sinus.The csf leak was patched with a mucosal graft and duraseal and the fess procedure was completed as planned.The patient stayed overnight in the hospital after the procedure and was reported to be doing well after being discharged from the hospital the next day.It was reported that the physician felt that the csf leak may have been caused by his probing with a seeker more than the balloon inflation itself.However, the cause was not determined after the fact.It was also reported that this was the first time the physician had used the rigid non-acclarent device.The relieva scout® multi-sinus was reported to have functioned as expected.There were no reported malfunctions with any acclarent devices used during this procedure.

• Brand Name: RELIEVA SCOUT® MULTI-SINUS DILATION SYSTEM 6X24MM (5 PK)
• Common Device Name: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 33 technology drive; irvine 92618
• MDR Report Key: 7162769
• Report Number: 3005172759-2017-00060
• Device Sequence Number: 63667
• Product Code: LRC
• UDI-Device Identifier: 10705031238039
• UDI-Public: (01)10705031238039(11)160809(17)170809(10)160809A-PC
• Combination Product (Y/N): N
• PMA/510(K) Number: K120280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

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: SCT0624MFS
• Device Lot Number: 160809A-PC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1