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 Cerebrospinal Fluid Leakage (1772)

Event Date 10/25/2022

Event Type  Injury  

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.Complaint reference number (b)(4) has two reports: (1) manufacture report number # 2029046-2022-02907 for product code fg200000 (trudi¿ navigation system).(2) importer report number # 3005172759-2022-01001 product code fg200000 (trudi¿ navigation system).

Event Description

It was reported that a patient who underwent ent (ear, nose & throat) procedure with a trudi¿ navigation system which encountered location inaccuracy issues and the patient suffered cerebrospinal fluid leak.It was reported that there were constant accuracy issues on the trudi¿ navigation system with all the devices involved in the procedure devices about halfway through the procedure.It was noted that the system was reregistered a few times and the issue would temporarily resolve, but as the case proceeded, the issue would occur again.It was also noted that the emitter pad had moved slightly, and the patient's head had moved a few times throughout the procedure.It was also noted that the patient was in reverse trendelenburg and angled to the physician and lowered on the bed by a few inches.The procedure was successfully completed.It was also reported that the patient was discharged following the ent procedure on (b)(6) 2022 and the patient went to the er on (b)(6) 2022.No patient's symptoms were reported and no information on how the cerebrospinal fluid leak was verified.No information was provided regarding medical intervention required but the patient was reported to be in stable condition.Per the physician¿s opinion, the injury occurred due to the medtronic drill.It was also noted that the acclarent curette possibly caused the injury.Additional information was later received indicating that when the reported accuracy issues were observed, the icon on the trudi¿ navigation system for all the products were green.There was no error message on the trudi¿ navigation system 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¿ navigation system 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 head was also moved quite a few times throughout the procedure.Multiple attempts have been made to obtain additional details regarding this event and the trudi¿ navigation system performance during the surgery, however, no such information has been received.Therefore, based on the information available, this event will be conservatively reported for the patient adverse event and product malfunction.

Manufacturer Narrative

On 23-nov-2022, additional information was received providing the procedure times for the case.In room at 1314, stop 1708, out of room at 1711.Device evaluation details: on 8-dec-2022, the device evaluation was completed.The biosense webster inc.(bwi) field service engineer (fse) tested the system for accuracy.Noise and cube tests passed.No problem was found.The system performed according to its specifications.In addition, the issue was investigated by the manufacturer.It was confirmed that there is no evidence in the log file of the mentioned re-registration.It was also confirmed that the emitter pad movement did not affect location accuracy.There were some sunken points on the nose and left sidelobe, and some points were acquired in the air were mistakenly taken by user during initial registration, but it did not cause accuracy problems with the trudi systems.The possibility that the curette was involved in the injury was also examined.The curette was used for a short time during the procedure, and there was no evidence of the curette being in the suspected injury area.In conclusion, there is no evidence of trudi system inaccuracy or curette involvement in the injury.Non-trudi issue.The history of customer complaints reported during the last year associated with carto 3 system # 100337 was reviewed, 1 additional complaint was found that is similar to this reported issue.A manufacturing record evaluation was performed for the carto 3 system # 100337, and no internal actions 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

On 4-jan-2023, the manufacturing date of 7-jun-2020 was received.The information has now been added to field h4.Device manufacture date.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 17-jun-2023, it was noticed incorrect information was reported in section h10 the 3500a supplemental (follow-up) # 1.Please consider this correction: incorrect references were made to a carto 3 system # 100337, however, the correct reference should be trudi system # (b)(4).

Manufacturer Narrative

On 1-sep-2023, additional product investigation identified a software defect which affects the location accuracy of the curette tool on the trudi system display.The issue is being addressed as part of an internal corrective action.This software defect has been reassessed as a reportable product malfunction as of 1-sep-2023.As such, field h6.Investigation findings has been updated with new coding of incorrect data definition (c100203).9.Fda correction/ removal reporting no: 3005172759-09182023-001-c.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

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on (b)(6) 2023, it was noticed the component code was inadvertently omitted from the supplemental mdr # 4.As such, field h6.Component code has now been populated with "computer software (g02008)".

• 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: 15844941
• MDR Text Key: 304121827
• Report Number: 2029046-2022-02907
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/28/2023

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: 10/25/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 01/04/2023; 06/17/2023; 09/01/2023; 11/19/2023
• Supplement Dates FDA Received: 12/20/2022; 01/17/2023; 07/12/2023; 09/28/2023; 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 3005172759-09182023-001-
• Patient Sequence Number: 1
• Treatment: ACCLARENT CURETTE.; MEDTRONIC DRILL.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male