MAUDE Adverse Event Report: ACCLARENT, INC. SPINPLUS, 5X16MM, 3 GUIDE; RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM

Catalog Number	RSP0516MFSZ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	11/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the "patients¿ right eye lid and lower lid filled with saline.This occurred during the irrigation procedure of the right maxillary sinus ballooning.Post surgery investigation revealed through the medtronic stealth navigation system a possible dehiscence that did not show up very well in ct scans.Surgery was ended and patient was woken up to confirm vision status, for safety reasons." it was subsequently reported that there was no error of the product, but a reaction the patient had during the irrigation process." additionally, the product was thrown away.
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
N/a.
Additional Manufacturer Narrative
Additional information/b5 narrative: the doctor reported that the patient recovered fully and experienced no vision issues.Evaluation of the relieva spinplus, 5x16mm, 3 guide (rsp0516mfsz) used during the reported event was not performed, as the ent consultant stated the product was thrown out.Additionally, no product malfunction or defect was reported.The provided information suggests that the cause of the right eye lid and lower lid filling with saline was due to the presence of a bony dehiscence.According to the spinplus instructions for use (ifu), the following warning is stated: "to prevent inadvertent fluid extravasation, such as into the orbit, do not irrigate in the presence of a bony dehiscence or defect in any sinus wall." the irrigation was performed despite the presence of the bony dehiscence.

• Brand Name: SPINPLUS, 5X16MM, 3 GUIDE
• Common Device Name: RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM
• 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: 23704030
• Report Number: 3003418325-2025-00064
• Device Sequence Number: 13441887
• Product Code: LRC
• UDI-Device Identifier: 20705031232829
• UDI-Public: 20705031232829
• Combination Product (Y/N): N
• PMA/510(K) Number: K143541
• 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): 12/31/2025

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: RSP0516MFSZ
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 12/31/2025
• 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: Other
• Patient Sex: Unknown