BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR

    MDR report key: 17812454 · Received September 25, 2023

    Report

    Report Number
    3023245-2023-00018
    Event Type
    Injury
    Date Received
    September 25, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 22, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008838
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE THAT INCLUDED A SOUNDSTAR CATHETER. THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AT BASELINE, THERE WAS NOTHING NOTICED IN THE PATIENT. RIGHT AFTER THE SOUNDSTAR CATHETER WAS IN THE BODY TRACING CARTOSOUND CONTOURS, THE PATIENT STARTED MOVING. THE PHYSICIAN HAD THE PATIENT INTUBATED. RIGHT BEFORE GOING TRANSSEPTAL, THE PHYSICIAN CHECKED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE), AND NOTICED A LARGE PERICARDIAL EFFUSION PRESENT. THE PERICARDIAL EFFUSION WAS ALSO CONFIRMED ON ICE. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS. ABOUT 190ML OF FLUID WAS REMOVED FROM THE PATIENT, DURING THE PERICARDIOCENTESIS. THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT (CCU) AND IS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 05-SEP-2023. NO ABLATION OCCURRED. NO RF CATHETER WAS USED IN THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11-SEP-2023. DISCOVERED DURING THE USE OF ICE FOR BASELINE IMAGES. PERICARDIOCENTESIS PERFORMED IN LAB. PATIENT RECOVERED IN CCU AFTER 1 DAY EXTENDED STAY. PER THE PHYSICIAN, THE PATIENT FULLY RECOVERED. NO RADIO FREQUENCY (RF) CATHETER USED IN PROCEDURE, NO ABLATION PERFORMED AND NO TRANSSEPTAL PUNCTURE PERFORMED. ONLY THE SOUNDSTAR CATHETER AND A COMPETITIVE DIAGNOSTIC WAS UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833851 SOUNDSTAR CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC E5163969 10846835008838

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| H| R NON BWI DIAGNOSTIC CATHETER