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 07/07/2022

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 complaint product was received in the product analysis lab on 28-jul-2022.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 (220523c-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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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, the wire of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 220523c-pc) was inaccurately displayed on the trudi system.The patient was registered without resolution.The balloon was replaced and the issue was resolved.On 16-jul-2022, additional information was provided.The additional information indicated that when the accuracy 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 device was plugged in after registration.The patient tracker did not move.The patient tracker cable was not under tension in relation to the reported event.Only one computed tomography (ct) scan was attempted to be used with the device; the ct image used was the primary image.The number of slices on the ct scan is not known.The reported inaccuracy issue was determined by the physician that it was not close to where he was on the anatomy.The inaccuracy was not within 2mm.There was no ferromagnetic material placed within the trudi zone.The crosshairs did not turn yellow.Neither the emitter pad nor the patient moved.There was other device¿ shaft in the proximity to an emitter pad¿s transmitter.On 20-jul-2022, additional information was received.The information indicated that the inaccuracy ¿might have been around 2 millimeters.¿ it also indicated that ¿the reason for inaccuracy was not due to any ferromagnetic interference or anything with the trudi.It was due to the wire itself being beat up and losing accuracy and durability.¿ based on the additional information received, on 16-jul-2022, the event has been deemed 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.[conclusion]: the healthcare professional reported that during an in-office primary balloon sinuplasty (bsp) procedure, the wire of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 220523c-pc) was inaccurately displayed on the trudi system.The patient was registered without resolution.The balloon was replaced and the issue was resolved.On 16-jul-2022, additional information was provided.The additional information indicated that when the accuracy 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 device was plugged in after registration.The patient tracker did not move.The patient tracker cable was not under tension in relation to the reported event.Only one computed tomography (ct) scan was attempted to be used with the device; the ct image used was the primary image.The number of slices on the ct scan is not known.The reported inaccuracy issue was determined by the physician that it was not close to where he was on the anatomy.The inaccuracy was not within 2mm.There was no ferromagnetic material placed within the trudi zone.The crosshairs did not turn yellow.Neither the emitter pad nor the patient moved.There was other device¿ shaft in the proximity to an emitter pad¿s transmitter.On 20-jul-2022, additional information was received.The information indicated that the inaccuracy ¿might have been around 2 millimeters.¿ it also indicated that ¿the reason for inaccuracy was not due to any ferromagnetic interference or anything with the trudi.It was due to the wire itself being beat up and losing accuracy and durability.¿ 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 a decontamination pouch.Visual inspection was performed.A kink was observed at the distal tip of the guidewire.The returned device underwent electrical functionality test and it was confirmed to be within specifications for all the connectivity and isolation values.The device was connected to the trudi system and brought above the emitter pad (trudi zone), which caused the status bar to be highlighted green.The device had normal connection and response.Additionally, the complaint device was held in known position on a test cube, and the caliper tool in the trudi planning tab was used to measure the distance between the crosshair representing the device tip location and the actual position on the test cube.Measurement obtained was 1.7mm; the trudi® navigation system provides a navigated tool tip location accuracy within 2 mm.Although the measurement obtained of 1.7 mm is fairly consistent with the inaccuracy that ¿might have been around 2 millimeters,¿ the device performed within specifications in the laboratory setting.Therefore, the reported issue documented in the complaint regarding the device being inaccurately displayed in the trudi system could not be confirmed.Though no product defect was identified, there may have been other circumstances and/or issues that occurred during the use of the device that could not be replicated during the analysis.A review of manufacturing documentation associated with this lot (220523c-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.As part of acclarent quality process all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.It should be noted that product failure could be caused by multiple factors.Instructions for use 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: RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15136521
• MDR Text Key: 304803980
• Report Number: 3005172759-2022-00017
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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: 220523C-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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