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 Stroke/CVA (1770); Perforation of Vessels (2135)

Event Date 06/23/2022

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

It was reported that a patient underwent a nasal/sinus endoscopy with a trudi¿ navigation system and the patient experienced carotid artery injury that resulted in a stroke.The patient sustained an injury to her carotid artery during a sinus procedure on (b)(6) 2022, which was reported to be the cause of her suffering a catastrophic stroke.M.D.Who performed the sinus procedure (a balloon sinuplasty), used a navigation balloon dilation system along with other component parts manufactured by acclarent.Additional products include the trudi¿ navigation system.It is believed the acclarent navigation balloon dilation system and it¿s component parts, including any al (artificial intelligence software) may have malfunctioned and failed to perform as intended during the procedure and as a result the patient's carotid artery was injured.There is no information about the hospitalization or what medical intervention was performed.No additional information has been made available.Although no specific malfunction was reported with the trudi¿ navigation system the adverse event is being conservatively reported.

• 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: 18970277
• MDR Text Key: 338505919
• Report Number: 3005172759-2024-50001
• 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: 02/29/2024,03/25/2024

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: 02/28/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• 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
• Treatment: ACCLARENT NAVIGATION BALLOON DILATION SYSTEM
• Patient Outcome(s): Life Threatening