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

Catalog Number	RSP0616MFSN
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
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 during an in-office balloon sinuplasty procedure, the tip of the navigated wire of the spinplus nav 6x16mm 3 guide (rsp0616mfsnz) became too kinked for the surgeon to complete the procedure with the device."it was permanently kinked in three different locations." it was reported that there was a 30 minute delay during the procedure.No patient adverse event occurred.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
Updated fields: d4 (expiration date), d9, g3, g6, h2, h3, h6, h11.Additional information: b5.Product was used in treating the frontal, maxillary, and sphenoid sinuses.The reported relieva spinplus nav balloon sinuplasty system, 6 x 16 mm, 3 guide kit (rsp0616mfsnz) was not returned to the manufacturer; therefore, an evaluation of the product could not be performed.A review of the device history record (dhr) was performed for the provided lot number and no non-conformances and/or manufacturing irregularities were identified related to the reported failure.The complaint could not be confirmed.The investigation did not find any indications of manufacturing, workmanship, or material deficiency.The instructions for use (ifu) for spinplus nav was reviewed.The ifu states device preparation step: "remove the desired relieva spin sinus guide catheter tip from its sterile packaging onto the sterile field.Inspect the device.Note: each sinus guide catheter tip is designed to target specific sinus anatomies.Select the appropriate guide tip based on the targeted sinus." 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.

• 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: 24112340
• Report Number: 3003418325-2026-00002
• Device Sequence Number: 20293814
• Product Code: PGW
• UDI-Device Identifier: 20705031245430
• UDI-Public: 20705031245430
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: Health Professional
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 250818A-PC
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/04/2026
• 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
• Patient Sex: Unknown