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 02/21/2023

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.The product was received in the product analysis lab on 08-mar-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.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 primary hybrid functional endoscopic sinus surgery (fess) procedure, ¿upon using the balloon catheter [a 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 221130b-pc)] it was observed that it was unable to navigate correctly.¿ the balloon catheter was replaced, the issue was resolved and the procedure continued.There was report of any negative patient impact.On 23-feb-2023, additional information was received.The information provided clarification to the event description, ¿unable to navigate correctly¿ as follows, ¿no error message, the physician could tell the accuracy was off.No other instruments had bad accuracy.¿ there was no difficulty experienced during the advancement of the device inside the patient¿s anatomy.There was no damage observed to the device.When the accuracy issue was observed, the icon on the trudi system was green.The device was plugged in after registration.The patient tracker was not moved and the patient tracker cable was not under tension in relation to the reported accuracy issue.Computer tomography (ct) image was the primary image used; the ct slices were 0.5mm.It was not known how many slices the scan contained.The inaccuracy was determined by the physician comparing to other instruments.There was no ferromagnetic material placed within the trudi zone.The crosshairs did not turn yellow.The emitter pad did not move and the patient did not move.It is not known if the inaccuracy was within 2mm.Based on the additional information received on 23-feb-2023, when the accuracy issue was observed, the icon on the trudi nav system was green, the event has been determined to be reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation 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.The guidewire was observed to be kinked at the distal tip.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 trudi system and brought above the emitter pad (trudi zone), which caused the status bar to be highlighted green.Device had normal connection and response.The kink observed was not originally documented in the complaint, and the complaint detailed that no physical damage was reported as a result of the issue encountered during the procedure, therefore, the most likely time of occurrence of this damage is the post-operative handling of the device and is considered unrelated to the issue as reported.The issue documented that the device was unable to navigate correctly could not be evaluated through functional test due to the kink damage present on the guidewire.With the evidence available, it is not possible to provide a clear insight into the root cause and/or exact contributing factors that may have resulted in the reported failure mode.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.As part of acclarent quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use (ifu) states that sinus navigation guidewire is a precision instrument and must be handled with care.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 CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 16524735
• MDR Text Key: 311570539
• Report Number: 3005172759-2023-00011
• 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
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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