MAUDE Adverse Event Report: ACCLARENT, INC. SPINPLUS NAV 6X16MM 3 GUIDE; RELIEVA

Catalog Number	RSP0616MFSN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/13/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that in-office balloon sinuplasty using relieva spinplus nav balloon was performed on a patient.¿the patient died from cardiac arrest an hour after leaving the office¿.It was confirmed that no malfunction of the device occurred during the procedure.Both the balloon and sinuplasty system functioned properly.The patient reportedly did not exhibit any signs or symptoms during the procedure.Relevant patient medical and surgical history is as follows: congestive heart failure, hypertension, cardiac pacemaker.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The spinplus navigated balloon (b)(6) was not returned and lot number information was not provided; therefore, device analysis could not be performed and device history record could not be reviewed.A medical assessment was performed to evaluate the possible relation between the reported event and product use.The assessment concludes the following: ¿based on the complaint information received and reviewed to date, there is no evidence to suggest that the sinus dilation device directly contributed to the patient's death.The patient was a 81-year-old male with significant underlying cardiovascular comorbidities, including congestive heart failure, hypertension, and a permanent pacemaker.The patient underwent an in-office balloon sinuplasty procedure.There were no reports of device malfunction, performance issues, or procedural complications.The balloon catheter and handpiece functioned as intended, and the procedure was completed without incident.Given the patient's age and substantial pre-existing cardiovascular disease, these factors represent well-established risk contributors for perioperative cardiac events, independent of the sinus dilation procedure.Based on the information currently available, a causal relationship between the device and the reported cardiac arrest cannot be established." if additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h11.Corrected field: b5.It was reported that in-office balloon sinuplasty using relieva spinplus nav balloon was performed on a patient, treating bilateral sinuses.It was reported that the device was connected to irrigation and/or suction; however, it was not specified whether irrigation, suction, or both were used.

• Brand Name: SPINPLUS NAV 6X16MM 3 GUIDE
• Common Device Name: RELIEVA
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; 31 technology drive; CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine; CA 92618
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24324825
• Report Number: 3003418325-2026-00004
• Device Sequence Number: 9475990
• Product Code: PGW
• UDI-Device Identifier: 10705031241015
• UDI-Public: 10705031241015
• Combination Product (Y/N): N
• PMA/510(K) Number: K171687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: RSP0616MFSN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/07/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Male