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

Catalog Number FG200000

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Perforation of Vessels (2135); Unspecified Nervous System Problem (4426)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

Importer reference#: (b)(4).There was no information provided to indicate the specific trudi system that was used during this procedure.Since there is no clarification, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.A manufacturer record evaluation cannot be conducted because the no serial number was provided by the customer.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.

Event Description

A patient underwent a balloon sinuplasty procedure with a with a trudi¿ navigation system and the patient experienced carotid artery injury that required intubation and balloon inflation in the sinus to stop bleeding and prolonged hospitalization.It was initially reported that the dilation of the sphenoid sinus led to the carotid artery blowing.They left the balloon inflated in the sinus to stop the bleeding.Emergency medical technicians (emt)s came and had to intubate.The patient was doing better.The physician¿s opinion, on what contributed to the adverse event is that it was the patient¿s unique anatomy.Physician did not feel acclarent technology was defective or responsible for the injury.Other details provided included that the balloon was inflated twice before the complaint occurred.0 degree scope was used.Patient has not undergone a previous sinus procedure.There were no performance issue / device malfunction associated with the acclarent balloon acclarent devices during the procedure.On 11-mar-2024, additional information was receive indicating the patient¿s injury to the carotid artery during a sinus procedure on (b)(6) 2023, caused her catastrophic neurological injuries.It is believed the al (artificial intelligence software) in the trudi¿ navigation system may have malfunctioned and failed to perform as intended during the procedure.Although no specific trudi¿ navigation system device malfunction was mentioned and with limited information available, the adverse event is being conservatively reported under the trudi device.

• 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
• MDR Report Key: 19036483
• MDR Text Key: 339294755
• Report Number: 3005172759-2024-50002
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024,04/03/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: FG200000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female