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 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

(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 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 (201111a-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.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 revision primary balloon sinuplasty (bsp) procedure, during the treatment of bilateral frontal and maxillary sinuses, the accuracy of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 201111a-pc) was off by ¿several millimeters.¿ the patient was registered three times without resolution.Magnetic interference was checked.The ¿dongle¿ was replaced without resolution.The 6mm x 16mm relieva spinplus navigation balloon sinuplasty system was replaced with a non-navigation lighted balloon and the issue was resolved.The procedure was successfully continued.There was no report of any patient adverse event or complication.Additional information was received on 16 nov 2021.The information indicated that when the accuracy issue was observed, all the icons on the trudi system were green.There was no error message on the trudi nav monitor for the device.The information indicated that it is not known if the device was plugged in before or after registration (i.E., using the registration probe); it is possible that it was plugged in after but this is not conclusive.The patient tracker was not moved.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.It is not known how many slices the ct scan contained.The inaccuracy was visually determined; the physician commented that he was touching the middle turbinate with the guidewire, and the system was showing crosshairs almost 5mm away.The inaccuracy was not within 2mm.The physician continued checking visible reference point and the trudi and noticed the major differences.It was not known if the crosshairs turned yellow.There was no ferromagnetic material placed within the trudi zone.The emitter pad was moved as a troubleshooting measure, it was adjusted.The patient was then re-registered.No other device¿s shaft was in proximity to the emitter pad¿s transmitter.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 06-dec-2021.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 investigational finding of the returned device.[conclusion]: the healthcare professional reported that during an in-office revision primary balloon sinuplasty (bsp) procedure, during the treatment of bilateral frontal and maxillary sinuses, the accuracy of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 201111a-pc) was off by ¿several millimeters.¿ the patient was registered three times without resolution.Magnetic interference was checked.The ¿dongle¿ was replaced without resolution.The 6mm x 16mm relieva spinplus navigation balloon sinuplasty system was replaced with a non-navigation lighted balloon and the issue was resolved.The procedure was successfully continued.There was no report of any patient adverse event or complication.Additional information was received on 16 nov 2021.The information indicated that when the accuracy issue was observed, all the icons on the trudi system were green.There was no error message on the trudi nav monitor for the device.The information indicated that it is not known if the device was plugged in before or after registration (i.E., using the registration probe); it is possible that it was plugged in after but this is not conclusive.The patient tracker was not moved.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.It is not known how many slices the ct scan contained.The inaccuracy was visually determined; the physician commented that he was touching the middle turbinate with the guidewire, and the system was showing crosshairs almost 5mm away.The inaccuracy was not within 2mm.The physician continued checking visible reference point and the trudi and noticed the major differences.It was not known if the crosshairs turned yellow.There was no ferromagnetic material placed within the trudi zone.The emitter pad was moved as a troubleshooting measure, it was adjusted.The patient was then re-registered.No other device¿s shaft was in proximity to the emitter pad¿s transmitter.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the complaint device was received.Visual inspection was performed.It was observed that the spinplus nav was returned with a kink at the distal tip of the guidewire.The returned device was tested for electrical functionality and the device passed.All values were observed to be within specification.The device was connected to the trudi system and it was correctly recognized.The icon display was green.The device was then inserted into hole #6 of the test cube until the distal tip made contact with the solid wall.An estimated measurement was taken in planning mode in the interface from the sensor location to the cube wall.A 1.3mm gap was found.The complaint documented that during the procedure while treating bilateral frontal and maxillary sinuses, the accuracy of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system was off by ¿several millimeters.¿ additional information indicated that when the accuracy issue was observed, all icons on the trudi system were green.The physician commented that he was touching the middle turbinate with the guidewire, and the system was showing crosshairs almost 5mm away.The inaccuracy was not within 2mm.The physician continued checking visible reference point and the trudi and noticed the major differences.It was not known if the crosshairs turned yellow.The 6mm x 16mm relieva spinplus navigation balloon sinuplasty system was replaced with a non-navigation lighted balloon and the issue was resolved.The procedure was successfully continued without any patient complication.All values were observed to be within specification during the electrical functionality test; the device performed without issue, the observed kink on the device guidewire may have contributed to the reported customer experience at the procedure time related to the accuracy issue.As a result of this condition, the reported customer issue was confirmed.A review of manufacturing documentation associated with this lot (201111a-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.It should be noted that product failure is multifactorial.However, 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: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12910740
• MDR Text Key: 283603086
• Report Number: 3005172759-2021-00016
• 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
• Report Date: 01/05/2022

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 Expiration Date: 11/11/2022
• Device Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 201111A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/06/2021; 01/05/2022
• Supplement Dates FDA Received: 12/06/2021; 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• 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