MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI NAV SUCTION; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	TDNS000Z
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.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.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.
Event or Problem Description
The healthcare professional reported that, during a primary functional endoscopic sinus surgery (fess) procedure, there was a issue with the registration accuracy of trudi suction, 0 - 1pk (tdns000z, lot unknown).The caller states that the physician reports that the navigant tools do not align with the initial registration during the procedure.There was no allegation that a death or serious injury occurred due to the use of the product.There was no report of the patient requiring medical intervention as a result the alleged product issue.Additional event information was received on 16-oct-2024 indicating that the customer confirm accuracy using the registration probe after registration process was completed.The customer confirmed accuracy known landmarks in endoscopic visualization inside the nasal cavity.The inaccuracy was determined when placing the navigable instruments in the nose.The inaccuracy was first noticed upon placing a straight suction into the nose.The accuracy validated was used by both the registration probe and through instrumentation.The ct image used as the primary image and there were no noticeable defects to the ct scanned image.The registration was performed by the surgeon who has done over 100 registrations.Anatomy accuracy was confirmed in multiple spots.There was no potential for metal interference.The registration process was not restarted nor redone after the initial finding.The issue was isolated to one patient, but skeptical of other cases.The patient tracker did not move nor the patient tracker cable under tension in relation to this event.No ferromagnetic material was placed within the trudi zone.The emitter pad was not moved.There was no other device¿s shaft in proximity to an emitter pad¿s transmitter.Trudi software version: 2.3.2.3.The information indicated that when the issue with the suction device occurred, the icon on the trudi system was green.There was no error message.The device was plugged in after registration.The crosshairs did not turn ¿yellow¿.The inaccuracy was not within 2mm.Additional event information received on 18-oct-2024 reported that the inaccuracy was noticed with the spinplus navigation balloon sinuplasty system (product code and lot number unknown) and the navwire navigation guidewire (product code and lot number unknown).
Additional Manufacturer Narrative
Product complaint (b)(4) updated sections on this med watch.Additional event information received on 11-nov-2024 indicated that when the accuracy issue was observed, the device icon on the trudi system monitor was green.There was no error message on the trudi nav monitor.They plugged the device after registration.The crosshairs turn did not turn yellow.The inaccuracy was within 2 mm.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: TRUDI NAV SUCTION
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): VIANT MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20635306
• Report Number: 3005172759-2024-00092
• Device Sequence Number: 15304744
• Product Code: PGW
• UDI-Device Identifier: 10705031245877
• UDI-Public: 10705031245877
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K180948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: TDNS000Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAVWIRE NAVIGATION GUIDEWIRE.; SPINPLUS NAVIGATION BALLOON SINUPLASTY SYSTEM.
• Patient Sex: Unknown