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

Catalog Number RSP0616MFSN

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is lrc/pgw.Section e.1: the initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (230911a-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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed 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 using a 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 230911a-pc) a day after the completion of a software update on the trudi navigation system (fg200000 / serial #: (b)(6)) , the accuracy seemed to be off according to the physician.It was reported that the accuracy was off ¿by multiple millimeters.¿ rebooting did not resolve the issue.The complaint balloon was replaced and the accuracy ¿seemed to be improved but not completely resolved.¿ there was no report of any negative patient impact.On 24-oct-2023, additional information was received.Per the information, computed tomography (ct) image was used as the primary image.The number of slices contained on the ct scan is not known.Not more than one c scan was attempted to be used with the device.The patient tracker did not move and the patient tracker cable was not under tension in relation to the reported accuracy being off issue.There was no ferromagnetic material placed within the trudi zone.The emitter pad did not move.The patient did not move.When the accuracy issue was observed, the bar below the device icon on the trudi system monitor was green.There was no error message on the trudi navigation monitor for the balloon device.The spinplus navigation balloon catheter was plugged in after registration.Per the information, the accuracy issue was determined by checking the landmarks on multiple anatomy.¿it was clear [that] navigation was off especially near the sphenoid sinuses, multiple re-registrations with the same outcome.¿ the crosshairs did not turn yellow.The additional information also indicated that the accuracy was confirmed using the registration probe after the registration process was completed.The end user did confirm accuracy of known landmarks in endoscopic visualization inside the nasal cavity using the balloon.It was then that the end user realized the accuracy was off.The inaccuracy was determined by checking multiple landmarks and re-registering multiple times.The inaccuracy was first noticed right when the spinplus nav balloon was placed inside the nose.The registration probe showed that accuracy was correct, the spinplus nav balloon show it was incorrect.Per the additional information, it was the surgeon who performed the registration and the surgeon was in serviced.The surgeon has experienced performing registration over 20 ties and this was the first time accuracy has been an issue for them.According to the additional information, accuracy was confirmed on the middle turbinate, face of sphenoid, junction of uncinate, front, and the inferior turbinate.The trudi software version was 2.3.2.3.Registration process was re-started after the initial finding.Based on the additional information received on 24-oct-2023, with the bar below the device icon on the trudi navigation system monitor being green when the accuracy issue was observed with the relieva spinplus navigation balloon catheter, the event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4) the purpose of this mdr submission is to report that the complaint device has not been returned for evaluation and analysis.If product is returned or information provided at a later date, the file will be updated accordingly.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 complaint product available to be returned for analysis, the reported issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 02-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 6mm x 16mm relieva spinplus navigation balloon sinuplasty system was received contained in the decontamination pouch.Visual inspection was performed.A 25-degree kink in the guidewire was observed about 40mm from the distal end of the guidewire.The electrical functionality was tested, and the device was confirmed to be within specifications for all the connectivity and isolation values.The device was then connected to the magnetic calibration system (magcs).A calibration check cycle was initiated.The calibration check was successful.The guidewire kink was not originally reported in the complaint, however, according to the risk documentation, loss of guidewire accuracy is a potential issue that can occur during guidewire placement due to guidewire damage.Therefore, the customer complaint was confirmed.However, there is no indication that the issue reported in the complaint is a result of a defect inherently related to the device, based on the results obtained from the electrical test and calibration check.A review of manufacturing documentation associated with this lot (230911a-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.As part of the acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.All devices are manufactured, inspected, and released to approved specifications as part of the acclarent quality process.It should be noted that product failure could be caused by multiple factors.However, the instructions for use state that sinus navigation guidewire is a precision instrument and must be handled with care.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.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: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18070079
• MDR Text Key: 328124709
• Report Number: 3005172759-2023-00052
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2024

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: Health Professional
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 230911A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 12/07/2023; 01/04/2024; 03/27/2024
• Supplement Dates FDA Received: 12/07/2023; 01/04/2024; 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2023
• 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
• Treatment: TRUDI NAVIGATION SYSTEM