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

Catalog Number	FG200000
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stroke/CVA (1770); Perforation of Vessels (2135)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: 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.Manufacturer's ref.# (b)(4).
Event or Problem 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.
Additional Manufacturer Narrative
Additional information was received indicating the serial number of the device involved was (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
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.Device investigation details: since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As a result, we are closing this investigation.Manufacturing record evaluations were performed for the trudi systems with serial numbers (b)(6) and (b)(6), and no internal actions were identified.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate and a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: TRUDI¿ NAVIGATION SYSTEM
• Common Device Name: 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: 18970741
• Report Number: 2029046-2024-01006
• Device Sequence Number: 17762154
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: FG200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/09/2025; 05/15/2025
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/06/2025; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACCLARENT NAVIGATION BALLOON DILATION SYSTEM
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown