MAUDE Adverse Event Report: ACCLARENT, INC. RELIEVA SPINPLUS NAV BALLOON SINUPLASTY SYSTEM, 6X16MM, 3 GUIDE KIT; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number RSP0616MFSN

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 06/09/2022

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 initial reporter email address is 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 (220504a-pc) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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, the accuracy of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system ((b)(4)) was off by 2 centimeters during the treatment in the sphenoid sinus.The balloon has not been previously inflated.The device was used with a zero degree scope.There was no non-acclarent devices used.The device was replaced and the reported issue was resolved; the procedure resumed without further incident.There was no report of any patient adverse event or complication.On 16-jun-2022, additional information was received.The information indicated that when the reported accuracy issue was observed, the icon on the trudi system was green.There was no error message on the trudi nav monitor.The information indicated that the device was plugged in after registration.The patient tracker was not moved and the tracker cable was not under tension in relation to this accuracy issue.No more than one computed tomography (ct) scan was attempted to be used with one device.The ct scan contains over 250 slices.The reported inaccuracy issue was determined via visual confirmation of a non-movable bone in the endoscopic view.There was no ferromagnetic material placed within the trudi zone.The crosshair did not turn yellow.The patient was under mobile anesthesia and did not move; the emitter pad was not moved.There was no other device¿s shaft in the proximity to an emitter pad¿s transmitter.Based on the additional information received on 16-jun-2022, that when the accuracy issue was observed, the icon on the trudi system was green, 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 that the product was received the product analysis lab on 05-jul-2022.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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 primary balloon sinuplasty (bsp) procedure, the accuracy of the 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / 220504a-pc) was off by 2 centimeters during the treatment in the sphenoid sinus.The balloon has not been previously inflated.The device was used with a zero degree scope.There was no non-acclarent devices used.The device was replaced and the reported issue was resolved; the procedure resumed without further incident.There was no report of any patient adverse event or complication.On 16-jun-2022, additional information was received.The information indicated that when the reported accuracy issue was observed, the icon on the trudi system was green.There was no error message on the trudi nav monitor.The information indicated that the device was plugged in after registration.The patient tracker was not moved and the tracker cable was not under tension in relation to this accuracy issue.No more than one computed tomography (ct) scan was attempted to be used with one device.The ct scan contains over 250 slices.The reported inaccuracy issue was determined via visual confirmation of a non-movable bone in the endoscopic view.There was no ferromagnetic material placed within the trudi zone.The crosshair did not turn yellow.The patient was under mobile anesthesia and did not move; the emitter pad was not moved.There was no other device¿s shaft in the proximity to an emitter pad¿s transmitter.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 electrical functionality was tested, and the ¿shield isolation from sensor¿ values were found to be out of specification.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 red.The error 3104 "connection failure" was displayed on the trudi screen.Due to this error, no further test could be performed.A review of manufacturing documentation associated with this lot (220504a-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.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The lack of accuracy as reported in the complaint could not be tested as the guidewire was kinked and a connection failure error appeared on the trudi screen.The guidewire kinking was not originally reported in the complaint; however, a review of the risk management files identified that the loss of accuracy is a risk associated with guidewire damage during use, such issue can occur during the guidewire placement.As such, the reported issue in the complaint was confirmed.Procedural factors not described in this complaint such as device preparation, device manipulation during the procedure, and patient¿s anatomy may have contributed to the guidewire kinking which ultimately might have led to the inaccuracy observed.However, this cannot be conclusively determined.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.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: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• 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: 14830983
• MDR Text Key: 294797905
• Report Number: 3005172759-2022-00013
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Device Lot Number: 220504A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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