BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUDI NAVIGATION SYSTEM

    MDR report key: 19036483 · Received April 3, 2024

    Report

    Report Number
    3005172759-2024-50002
    Event Type
    Injury
    Date Received
    April 3, 2024
    Date of Event
    May 19, 2023
    Report Date
    April 3, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    PGW
    UDI-DI
    10846835017182
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822574 TRUDI NAVIGATION SYSTEM EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT PGW BIOSENSE WEBSTER INC 10846835017182

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R| L