MAUDE Adverse Event Report: BIOSENSE WEBSTER INC TRUDI NAVIGATION SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number 1

Device Problems Image Orientation Incorrect (1305); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/23/2022

Event Type  Injury  

Event Description

It was reported that a male patient with recurrent fungal sinusitis who underwent ear, nose & throat revision procedure with trudi navigation system and an issue of ¿location inaccuracy¿ occurred and the experienced a soft tissue injury requiring surgical intervention.It was reported that a penetration/puncture of the skull base next to the posterior ethmoid area occurred during a revision sinus surgery.The caller reported that the suction device was displayed on the trudi system 1 cm from the skull base which resulted in the physician putting a hole in the skull base with the suction device.It was reported that when the physician placed the suction device at the point where he saw brain matter, the trudi system still displayed the suction device as 1 cm from the site.Additional medical intervention was required to preclude permanent impairment of a body function, the physician patched the hole and the general procedure was completed after, the patient was discharged the next morning and that the patient was in stable condition.Additional information was received indicating the trudi system was off by at least one (1) centimeter at a critical location near posterior ethmoid.The skull was penetrated inadvertently due to trudi accuracy being out of calibration.Patient had skull hole patched.He was released from hospital the following day.Aside from patching up the injury site, the patient did not receive further medical and/or surgical intervention.The physician used durgen and mucosal graft to patch up the injury site.There was evidence of cerebrospinal fluid (csf) leak at the injury site.The patient had undergone previous procedures prior to this revision procedure and the patient has a history of fungal rhinosinusitis that needed the removal of the remaining ethmoid cells.The patient has had no additional procedures since the repair; the patient had one prior surgery before this procedure during which the incident occurred.The physician did not identify any defect in the skull base pre-operatively, however, intra-operative endoscopy noted defect after removing the posterior ethmoid cell.The information indicated that the patient was admitted to the hospital due to the reported event.The patient is reported to be doing well without any deficit and any further csf leak.There was no deficit / residual symptoms after the patient was discharged.The information indicated that the physician moved to the other side / nasal cavity before returning and still seeing brain material.The physician used the trudi suction device to work in the other side / nasal cavity, there was accuracy issue, but it was not as significant an issue as with accuracy issue on the contralateral side.The medtronic shaver was not used until after the reported adverse event had occurred; it was not used in the same area before the reported event with the injury to the skull base was observed.The physician did not suspect the medtronic shaver as a contributing factor to the reported adverse event.The endoscope used was a zero-degree stryker endoscope.It was confirmed that accuracy was confirmed using the registration probe after registration process was completed at the beginning of the case.Surgeon placed the navigated suction device at point of skull defect and the trudi navigation cross-hairs indicated that the device was 1 cm away from the defect.The inaccuracy was noticed when the surgeon noted csf flowing from a defect near posterior ethmoids.Ct imaging was used as the primary image.The ct scan contained 1mm cuts.In this case it was the scrub nurse that did the registration in this case.Surgeon and scrub tech.Both have been inserviced and are quite comfortable with the process.Both the surgeon and the scrub tech have performed 30+ registrations and this is the first issue for both of these individuals.Rerromagnetic material was not seen placed within the trudi zone.The crosshairs did not turn yellow.The emitter pad nor the patient moved.No other device¿s shaft were close in proximity to the emitter pad¿s transmitter.The trudi device was plugged in after registration.In a follow up with the physician, they described it was a difficult revision case involving recurrent rhinofungal sinusitis with poor anatomy.Revision case involving rhinofungal sinusitis.Registration was performed by operating room nurse who traced with question on increased pressure on the skin.After registration physician noted it was normal when checking externally.However seemed more accurate on right then left.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster inc.'s reference number (b)(4) has two reports: manufacture report number # 2029046-2023-00166 for product code fg200000 (trudi¿ navigation system).Importer report number # (b)(4) for product code fg200000 (trudi¿ navigation system).

Manufacturer Narrative

It was reported that a male patient with recurrent fungal sinusitis who underwent ear, nose & throat revision procedure with trudi navigation system and an issue of ¿location inaccuracy¿ occurred and the experienced a soft tissue injury requiring surgical intervention.It was reported that a penetration/puncture of the skull base next to the posterior ethmoid area occurred during a revision sinus surgery.The caller reported that the suction device was displayed on the trudi system 1 cm from the skull base which resulted in the physician putting a hole in the skull base with the suction device.It was reported that when the physician placed the suction device at the point where he saw brain matter, the trudi system still displayed the suction device as 1 cm from the site.Additional medical intervention was required to preclude permanent impairment of a body function, the physician patched the hole and the general procedure was completed after, the patient was discharged the next morning and that the patient was in stable condition.Device evaluation details: it was confirmed with the physician that there was no error message on the trudi navigation system.The patient tracker, the patient, and the emitter pad didn't move during the procedure.In addition, it was stated that the registration was performed by the nurse.After the registration, the physician noted that the registration was normal externally, however, seemed more accurate on the right than left.The study data, which related to the reported issue, was exported from the system and it was sent to the unit manufacturer.It was confirmed that the reported inaccuracy was caused by bad registration that led to inaccuracy from the beginning of the case.The issue was related to user error.The system is operational.The history of customer complaints reported during the last year associated with trudi navigation system # (b)(6) was reviewed.No other similar complaint was found.A manufacturing record evaluation was performed for the trudi navigation system # (b)(6), and no internal action related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

The manufactured date has been provided.Therefore, field h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: TRUDI NAVIGATION SYSTEM
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16248991
• MDR Text Key: 308212761
• Report Number: 2029046-2023-00166
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1
• Device Catalogue Number: FG200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 05/04/2023; 06/18/2023
• Supplement Dates FDA Received: 06/01/2023; 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention