BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 11340284 · Received February 17, 2021

    Report

    Report Number
    2029046-2021-00191
    Event Type
    Death
    Date Received
    February 17, 2021
    Date of Event
    January 25, 2021
    Report Date
    January 25, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008845
    PMA / PMN Number
    K112050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 4/6/2021 CLARIFYING THAT THE REPORTED SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER USED WAS REPROCESSED AS THIS HOSPITAL ALWAYS USES REPROCESSED SOUNDSTAR CATHETERS. THE PRODUCT WAS UPDATED TO A REPROCESS SDSTR ECO 10F-90 GE / PRODUCT CODE R10439072 MANUFACTURED BY STERILMED, INC. WHICH IS A DISTRIBUTED DEVICE. THEREFORE, THIS EVENT IS NO LONGER MDR REPORTABLE FOR BWI. THE EVENT WILL BE REPORTED BY STERILMED MANUFACTURER REFERENCE #(B)(4). MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE G4043386 NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT ((B)(6) LBS) UNDERWENT A CARDIAC ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED VENTRICULAR FIBRILLATION (VFIB), MYOCARDIAL INFARCTION, AND DEATH. WHILE MAPPING IN THE RIGHT ATRIUM (RA), IN PREPARATION FOR ABLATION IN THE LEFT ATRIUM (PRIOR TO TRANSSEPTAL PROCEDURE), THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA, WAS CODED AND THEN EXPIRED. FIRST, A CARTOSOUND MAP WAS CREATED OF THE LEFT ATRIUM WITH THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER. A SMART TOUCH SF CATHETER (USED ONLY TO MAP THE RIGHT ATRIUM) WAS PLACED INTO THE CORONARY SINUS (CS) TO CREATE A FAST-ANATOMICAL MAPPING (FAM) MAP. THIS WAS REMOVED THEN THE CORONARY SINUS CATHETER WAS PLACED INTO THE CORONARY SINUS. NO RADIOFREQUENCY WAS DELIVERED AT ANY TIME. AT THIS POINT THE CERTIFIED REGISTERED NURSE ANESTHETISTS (CRNA) STATED TO THE PHYSICIAN THAT "THE PATIENT HAD A LOT OF CO2 CONSUMPTION," AND THAT "IT WOULD BE EASIER TO PARALYZE THE PATIENT." WHEN THE ANESTHESIOLOGIST CAME INTO THE ROOM TO PUT THE PATIENT UNDER GENERAL ANESTHESIA, THEY COMMENTED THAT THE PATIENT'S VITALS WERE "TANKING." THE PATIENT WAS THEN NOTICED TO BE IN VENTRICULAR FIBRILLATION (VFIB). THE NURSE PERFORMED CHEST COMPRESSIONS AND THE PATIENT WAS DEFIBRILLATED MULTIPLE TIMES. A PATIENT CODE WAS CALLED, AND THE CATH LAB TEAM CAME IN, CONTINUED ADMINISTERING CHEST COMPRESSIONS. THE CARDIOLOGIST PERFORMED AN ANGIOGRAM, A SHOT OF CONTRAST WAS ADMINISTERED TO ASSESS THE CORONARY ARTERIES, AND IT WAS NOTED THAT "PLAQUE CAME OFF" AND THE LEFT MAIN CORONARY ARTERY WAS VISUALIZED AS A "POOL OF BLOOD," NO CORONARIES WERE VISIBLE. THE PATIENT'S DEATH WAS CALLED. UPON REVIEW ON THE EP RECORDING SYSTEM, JUST PRIOR TO THE PATIENT ENTERING VF, THERE WERE ST SEGMENT ELEVATIONS IN THE INFERIOR LEADS WERE NOTED ON THE ELECTROCARDIOGRAM. PATIENT SUFFERED MYOCARDIAL INFARCTION OF LEFT MAIN ARTERY. THE PHYSICIAN DID NOT STATE THAT THEY BELIEVED BWI EQUIPMENT CONTRIBUTED TO THE PATIENT'S EVENT OR DEATH. PHYSICIAN RELATED THE CAUSE OF THE EVENT TO THE PATIENT¿S CONDITION AS THE PATIENT SUFFERED RIGHT VENTRICLE MYOCARDIAL INFARCTION. PATIENT¿S RELEVANT TESTS/LABORATORY DATA INCLUDED: CREATININE: 0.80, HEMOGLOBIN 16.8, INR 1.00. WITH THE INFORMATION AVAILABLE, THIS EVENT IS BEING CONSERVATIVELY ASSESSED AS MDR REPORTABLE UNDER THE SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AS IT WAS THE ONLY CATHETER INSIDE THE PATIENT¿S BODY AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236328 SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439072 G4043386 10846835008845

    Patients

    Seq Age Sex Outcome Treatment
    1