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 10/25/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a standard revision functional endoscopic sinus surgery (fess) procedure on (b)(6) 2022, the following devices were used: trudi curette (tdc0005 / lot# unknown), 0° trudi nav suction device (tdns000z / lot#: unknown), 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / lot# unknown), a trudi probe (catalog / lot# unknown), and a curve suction device (catalog / lot# unknown).There were constant accuracy issues on the trudi system with all of the devices about halfway through the procedure.The devices were re-registered a few times and the issue would temporarily be resolved, and as the case proceeded, the issue would recur.It was reported that the emitter pad had moved slightly and the patient¿s head had moved a few times throughout the procedure; it was noted that the patient was in a reverse trendelenburg and angled to the physician.The procedure was completed.It was reported that the patient was discharged on the same day following the procedure and the patient went to the emergency room (er) on (b)(6) 2022, due to a cerebrospinal fluid (csf) leak.Information related to the patient¿s symptoms and how the injury was confirmed are unknown.Medical intervention provided was also unknown.The patient was reported to be in stable condition.The treating physician thought that the injury occurred due to the medtronic drill; it was also reported that it was possible that the acclarent trudi curette (tdc0005 / lot# unknown) may have caused the csf leak injury.On 10-nov-2022, responses to additional information request were received.The information indicated that when the reported accuracy issue was observed, the icon on the trudi system for all the products 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 did not move; the patient tracker cable was not under tension in relation to this event; dpt was used.Computed tomography (ct) image was used as the primary image.The information indicated that 0.4mm resolution was in the ct scan.The inaccuracy issue was determined when anatomical landmarks inside the nose were not aligned to the trudi image.The inaccuracy was not within 2mm.The information stated the following, ¿mayo stand and metal instruments were used throughout the case so possible metal interference was experienced but nothing of note.¿ other device¿s shaft was not noted to be in the proximity to an emitter pad¿s transmitter.The crosshairs did not turn yellow.The emitter pad did move and the patient also moved; the patient was in a reverse trendelenburg and lowered on the bed by a few inches.Head was also moved quite a few times throughout the procedure.Based on the additional event information received on 10-nov-2022, with the loss of accuracy with the green icon, the event has been deemed reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, weight, and ethnicity were not provided.Procode is lrc/pgw.The expiration date of the device is not known as the device lot number is not available / not reported.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that during a standard revision functional endoscopic sinus surgery (fess) procedure on (b)(6) 2022, the following devices were used: trudi curette (tdc0005 / lot# unknown), 0° trudi nav suction device (tdns000z / lot#: unknown), 6mm x 16mm relieva spinplus navigation balloon sinuplasty system (rsp0616mfsn / lot# unknown), a trudi probe (catalog / lot# unknown), and a curve suction device (catalog / lot# unknown).There were constant accuracy issues on the trudi system with all of the devices about halfway through the procedure.The devices were re-registered a few times and the issue would temporarily be resolved, and as the case proceeded, the issue would recur.It was reported that the emitter pad had moved slightly and the patient¿s head had moved a few times throughout the procedure; it was noted that the patient was in a reverse trendelenburg and angled to the physician.The procedure was completed.It was reported that the patient was discharged on the same day following the procedure and the patient went to the emergency room (er) on (b)(6) 2022, due to a cerebrospinal fluid (csf) leak.Information related to the patient¿s symptoms and how the injury was confirmed are unknown.Medical intervention provided was also unknown.The patient was reported to be in stable condition.The treating physician thought that the injury occurred due to the medtronic drill; it was also reported that it was possible that the acclarent trudi curette (tdc0005 / lot# unknown) may have caused the csf leak injury.On 10-nov-2022, responses to additional information request were received.The information indicated that when the reported accuracy issue was observed, the icon on the trudi system for all the products 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 did not move; the patient tracker cable was not under tension in relation to this event; dpt was used.Computed tomography (ct) image was used as the primary image.The information indicated that 0.4mm resolution was in the ct scan.The inaccuracy issue was determined when anatomical landmarks inside the nose were not aligned to the trudi image.The inaccuracy was not within 2mm.The information stated the following, ¿mayo stand and metal instruments were used throughout the case so possible metal interference was experienced but nothing of note.¿ other device¿s shaft was not noted to be in the proximity to an emitter pad¿s transmitter.The crosshairs did not turn yellow.The emitter pad did move and the patient also moved; the patient was in a reverse trendelenburg and lowered on the bed by a few inches.Head was also moved quite a few times throughout the procedure.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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 accuracy issue could not be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.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 adverse event.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 is one of 5 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2022-00027, 3005172759-2022-00028, 3005172759-2022-00030, and 3005172759-2022-00031.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 23-nov-2022.[additional information]: on 23-nov-2022, additional information was received.The information included the patient initials, the patient¿s weight, and height; the information also indicated that a 16mm x 40mm relieva tract balloon dilation system was also used during the procedure; there was no device malfunction or failure reported related to the tract balloon dilation system.The information indicated that the device lot numbers are not obtainable.The patient was in the procedure room at 13:14 hour.The procedure was stopped at 17:08 hour, and the patient was out of the procedure room at 17:11 hour.This is one of 5 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2022-00027, 3005172759-2022-00028, 3005172759-2022-00030, and 3005172759-2022-00031.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: 15820207
• MDR Text Key: 308066745
• Report Number: 3005172759-2022-00029
• 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: 11/23/2022

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 Model Number: RSP0616MFSN
• Device Catalogue Number: RSP0616MFSN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ACCLARENT UNKNOWN PRODUCT.; MEDTRONIC DRILL.; RELIEVA TRACT BALLOON DILATION SYSTEM, 16X40MM.; TRUDI CURETTE, 0, 5IN.; TRUDI SUCTION, 0 - 1PK.; UNK_TRUDI PROBE.
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White