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 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure, it was reported that there was a ¿gross system inaccuracy¿ with the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 210303b-pc).It was reported that they registered the patient with the navigation system and ¿verified the accuracy of the system¿ and ¿observed a substantial inaccuracy against known anatomical structures.¿ there were two attempts at re-registration without resolution.The trudi system was rebooted without resolution.The procedure was continued with a non-navigational balloon.There was no report of any patient adverse event or complication.Additional information was received on 26 july 2021.The information indicated that when the issue was observed, the icon on the trudi system was green.There was no error message on the trudi nav monitor for the device.The patient tracker was not moved nor was the patient tracker cable under tension in relation to this event.There was not more than one computed tomography (ct) scan attempted to be used with one device.The ct image was used as the primary image.There was no ferromagnetic material placed within the trudi zone.The crosshair did not turn yellow.There was no movement out of the ordinary for an in-office procedure in terms of patient movement.It was reported that the accuracy was off by approximately 5mm, but only on 0.It was not known if the other device¿s shaft was in proximity to an emitter pad¿s transmitter.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (210303b-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 analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.To the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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, it was reported that there was a ¿gross system inaccuracy¿ with the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 210303b-pc).It was reported that they registered the patient with the navigation system and ¿verified the accuracy of the system¿ and ¿observed a substantial inaccuracy against known anatomical structures.¿ there were two attempts at re-registration without resolution.The trudi system was rebooted without resolution.The procedure was continued with a non-navigational balloon.There was no report of any patient adverse event or complication.Additional information was received on 26 july 2021.The information indicated that when the issue was observed, the icon on the trudi system was green.There was no error message on the trudi nav monitor for the device.The patient tracker was not moved nor was the patient tracker cable under tension in relation to this event.There was not more than one computed tomography (ct) scan attempted to be used with one device.The ct image was used as the primary image.There was no ferromagnetic material placed within the trudi zone.The crosshair did not turn yellow.There was no movement out of the ordinary for an in-office procedure in terms of patient movement.It was reported that the accuracy was off by approximately 5mm, but only on 0.It was not known if the other device¿s shaft was in proximity to an emitter pad¿s transmitter.

• 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 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12277947
• MDR Text Key: 265170442
• Report Number: 3005172759-2021-00010
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10705031241015
• UDI-Public: 10705031241015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2021

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
• Device Operator: No Information
• Device Expiration Date: 03/03/2023
• Device Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 210303B-PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1