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 02/02/2023

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 expiration date of the device is not known as the device lot number is not available / not reported.The device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device was 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 issue in the complaint cannot be confirmed.The lot number of the device is not known; therefore, manufacturing documentation review 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 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 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2023-00008 and 3005172759-2023-00009.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.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 procedure on (b)(6) 2023, the trudi navigation system (s/n: (b)(4)) was showing inaccuracies after several rounds of registration.A disposable patient tracker was initially used, and after inaccuracies were observed, a decision was made to switch to the reusable patient tracker.A spinplus navigation balloon sinuplasty system (rsp0616mfsn / lot# unknown) and a 0° trudi nav suction device (tdns000z / 2111120) were used.Once registered, the inaccuracies continued.Registration was done for a third time with continued inaccuracy.The physician was unable to do all they wanted to do with navigation during the procedure; therefore, the navigation portion of the procedure was aborted.After the procedure, the acclarent representative reportedly spent 2.5 hours troubleshooting with a model head.A new patient probe, a reusable patient tracker, a new spinplus navigation balloon sinuplasty system (rsp0616mfsn) were used during the troubleshooting; it was reported that the 0° trudi nav suction device (tdns000z / 2111120) used during the procedure was re-sterilized and was used during the troubleshooting.The accuracy improved, but it was still not completely accurate.The physician reportedly stated that they were comfortable enough to use the trudi for the next day¿s cases.On 06-feb-2023, additional information was received.The information indicated that the lot numbers of the devices were not available as the packaging had been discarded.When the accuracy issue was observed, the icon on the trudi nav system was green.The accuracy was off by more than 2mm.There was no error message on the trudi nav monitor for the device.Related to the 6mm x 16mm relieva spinplus navigation balloon, only one computed tomography (ct) scan was attempted to be used with the device.Ct image was the primary image used.The number of slices the ct scan contained is not known.The reported inaccuracy was determined for the complaint devices by touch the face of the sphenoid with a 0° trudi nav suction device.The information indicated that the model head was registered several times and inaccuracy was observed with the model head.There was no ferromagnetic material placed within the trudi zone.The crosshairs did not turn yellow.No other device¿s shaft was in the proximity to the transmitter of the emitter pad.Pertaining to the 0° trudi nav suction device, it was reprocessed, but the number of times it had been reprocessed is not known.It was reported that suction devices are reprocessed using an automated cleaning method in accordance with the instruction for use (ifu).Based on the additional information received on 06-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.¿ on 13-feb-2023, additional information was received.The information provided the lot numbers for the suction devices.The lot number of the 0° degree trudi nav suction device is 2111120.The information indicated that the suction device is reprocessed using an automated cleaning method in accordance with the instruction for use (ifu).There was no report of any negative patient impact or patient injury related to the reported inaccuracy issue with the devices.

• 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: 16449033
• MDR Text Key: 310370590
• Report Number: 3005172759-2023-00008
• 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: Physician
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• 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: TRUDI CABLE - 1PK