MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT

Model Number RSP0616MFSN

Device Problem Incorrect Interpretation of Signal (1543)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).A review of manufacturing documentation associated with this lot (200904a-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure targeting all six sinuses, there were inaccuracies in the guidance of the guidewire of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 200904a-pc) when the physician was maneuvering it inside the sinus.To troubleshoot, the balloon was re-registered, the patient tracker was reseated, and the physician tried a different sinus, and confirmed with the regional sales specialist that all troubleshooting was completed.The balloon was replaced, and the issue was resolved; the procedure was continued.It was reported that the trudi system is operating per specification and is not responsible for the reported product issue.There was no report of any patient adverse event or complication.On 21 december 2020, additional information was provided indicating that the icon on the trudi system was green, there was no error message.The device was plugged in after registration.The patient tracker did not move, and the patient tracker cable was not under tension in relation to the reported inaccuracies.There was no more than one computed tomography (ct) scan attempted to be used with one device and the device was not dropped nor mishandled in relation to the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to document the closure of the product investigation; the complaint device is not available to be returned for evaluation and analysis.[conclusion]: the healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure targeting all six sinuses, there were inaccuracies in the guidance of the guidewire of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system ((b)(6)) when the physician was maneuvering it inside the sinus.To troubleshoot, the balloon was re-registered, the patient tracker was reseated, and the physician tried a different sinus, and confirmed with the regional sales specialist that all troubleshooting was completed.The balloon was replaced, and the issue was resolved; the procedure was continued.It was reported that the trudi system is operating per specification and is not responsible for the reported product issue.There was no report of any patient adverse event or complication.On (b)(6) 2020, additional information was provided indicating that the icon on the trudi system was green, there was no error message.The device was plugged in after registration.The patient tracker did not move, and the patient tracker cable was not under tension in relation to the reported inaccuracies.There was no more than one computed tomography (ct) scan attempted to be used with one device and the device was not dropped nor mishandled in relation to the reported issue.Multiple attempts to obtain additional information related to the procedure, the reported device issue, and to obtain the product for analysis were unsuccessful.If additional information is available at a later date and the product is returned, the file will be updated accordingly.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (200904a-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product evaluation and analysis cannot be conducted as the product was not available to be returned.Determination of causes and possible contributing factors could not be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT
• Type of Device: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• MDR Report Key: 11198004
• MDR Text Key: 244234256
• Report Number: 3005172759-2021-00001
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031241015
• UDI-Public: 10705031241015
• Combination Product (y/n): N
• PMA/PMN Number: K171687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 200904A-PC
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1