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

Model Number RSP0616MFSN

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 03/21/2023

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.Procode is lrc/pgw.The name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot 221130b-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.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 in the complaint cannot be confirmed.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.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 a revision hybrid functional endoscopic sinus surgery (fess) procedure on (b)(6) 2023, there was accuracy issues with the patient tracker.When the patient tracker was taken off the tegaderm, it looked like there was a tear on the rubber piece on the tracker.The visual line of the patient and the visuals appeared off.It was reported that to troubleshoot, the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (b)(4) without resolution.The patient was re-registered several times; the patient tracker was taken off the tegaderm and saw the small tear in the tracker itself.There was no report of any negative patient impact.The complaint device is reported as not available to be returned for evaluation and analysis.On (b)(6) 2023, additional information was received.The information indicated that when the accuracy issue was observed, the color of the bar below the balloon icon on the trudi system monitor was green.There was no error message on the trudi nav monitor for the device.The device was plugged in the first time after registration.The information indicated that the patient tracker did not move; the patient tracker cable was not under tension in relation to this event, however, a small tear was noticed in the patient tracker during the troubleshooting.One computed tomography (ct) scan was used with one device; not more than one scan was attempted to be used.The ct scan image was the primary image used.The inaccuracy was determined by identifying landmarks within the nose during the procedure.The inaccuracy was within 2mm.There was no ferromagnetic material placed within the trudi zone.The crosshairs did not turn yellow.The emitter pad did not move; the patient did not move.Based on the additional information received on (b)(6) 2023, that when the accuracy issue was observed, the color of the bar below the balloon icon on the trudi system monitor was green, the event has been determined to be usfda reportable under title 21 cfr 803 with a classification of ¿malfunction.¿.

• 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 CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16686722
• MDR Text Key: 313237030
• Report Number: 3005172759-2023-00018
• 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
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 221130B-PC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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