BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER, 10F

    MDR report key: 18276073 · Received December 6, 2023

    Report

    Report Number
    2029046-2023-02836
    Event Type
    Death
    Date Received
    December 6, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008838
    PMA / PMN Number
    K112050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER, 10F EXPERIENCED CARDIAC ARREST AND DIED. WHEN THE ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER WAS INSERTED INTO THE PATIENT AT THE BEGINNING OF THE PROCEDURE AND JUST AFTER ACCESS WAS GAINED, IT WAS NOTICED BY ICE THAT THERE WAS NO CARDIAC MOVEMENT. THE ICE CATHETER WAS THE ONLY BWI CATHETER INSIDE OF THE PATIENT. RESUSCITATION EFFORTS WITH CPR AND DRUG ADMINISTRATION WERE PROVIDED. THE PATIENT HAD A TRACH PRIOR TO THE PROCEDURE AND THE PHYSICIAN BELIEVED THE DEATH MAY HAVE OCCURRED DUE TO HYPOXIA. THE CAUSE OF DEATH IS UNKNOWN DUE TO LIMITED INFORMATION. AS THE ULTRASOUND CATHETER WAS THE ONLY CATHETER INSIDE THE PATIENT'S BODY AT THE TIME OF THE CARDIA ARREST, IT CANNOT BE COMPLETELY DISSOCIATED AS A CONTRIBUTOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2137697 SOUNDSTAR 3D DIAGNOSTIC ULTRASOUND CATHETER, 10F CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10846835008838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| L