BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER

    MDR report key: 12632819 · Received October 14, 2021

    Report

    Report Number
    2029046-2021-01754
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 21, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008852
    PMA / PMN Number
    K140318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A MALE PATIENT, WEIGHING 146.8KG AND BORN ON (B)(6) 1953 UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. AT THE BEGINNING OF THE CASE, AFTER INSERTING THE PENTARAY CATHETER AND MAPPING THE RIGHT ATRIUM, THEY HAD THEN INSERTED THE SOUNDSTAR CATHETER INTO THE PATIENT. NO EFFUSION WAS NOTED AT THIS POINT. THEN ABOUT 30 MINUTES LATER, WHEN TAKING IMAGES WITH CARTOSOUND, IT WAS NOTICED THERE WAS A LARGE EFFUSION PRESENT ON THE IMAGE. THE PERICARDIAL EFFUSION WAS CONFIRMED ON ULTRASOUND ECHO. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS, AND ABOUT 1200 CC OF FLUID WAS REMOVED. THE PATIENT WAS THEN ADMITTED TO SURGERY. THE PATIENT WAS LAST REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN BELIEVES IT WAS ULTRASOUND CATHETER THAT WAS THE CAUSE OF THE ISSUE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS IMPROVED. DEVICE EVALUATION DETAILS: THE SOUNDSTAR ECO 8F ULTRASOUND CATHETER WAS RETURNED TO BIOSENSE WEBSTER INC. (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI CONDUCTED VISUAL INSPECTION, CARTO 3 VISUALIZATION, ACUSON ULTRASOUND AND ATLAS TRANSDUCER TESTS ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT IT WAS IN GOOD NORMAL CONDITION. THEN, CARTO 3 VISUALIZATION, ACUSON ULTRASOUND AND ATLAS TRANSDUCER TESTS WERE PERFORMED AND DEVICE PASSED THE TESTS. DEFLECTION TEST WAS PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS DEFLECTING CORRECTLY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED CATHETER BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE CATHETER THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. 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 · 1

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT, WEIGHING (B)(6) AND BORN ON (B)(6) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. DURING AN ATRIAL FIBRILLATION CASE, A PERICARDIAL EFFUSION WAS NOTICED IN THE PATIENT. AT THE BEGINNING OF THE CASE, AFTER INSERTING THE PENTARAY CATHETER AND MAPPING THE RIGHT ATRIUM, THEY HAD THEN INSERTED THE SOUNDSTAR CATHETER INTO THE PATIENT. NO EFFUSION WAS NOTED AT THIS POINT. THEN ABOUT 30 MINUTES LATER, WHEN TAKING IMAGES WITH CARTOSOUND, IT WAS NOTICED THERE WAS A LARGE EFFUSION PRESENT ON THE IMAGE. THE PERICARDIAL EFFUSION WAS CONFIRMED ON ULTRASOUND ECHO. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS, AND ABOUT 1200 CC OF FLUID WAS REMOVED. THE PATIENT WAS THEN ADMITTED TO SURGERY. THE PATIENT WAS LAST REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN BELIEVES IT WAS ULTRASOUND CATHETER THAT WAS THE CAUSE OF THE ISSUE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PATIENTS OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS IMPROVED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT; ADMITTED TO INTENSIVE CARE UNIT (ICU) AFTER SURGERY. ACTIVATED CLOTTING TIME (ACT) 360 AT TIME OF EVENT. NO ABLATION WAS PERFORMED AND NO ABLATION CATHETER WAS EVER INSERTED INTO THE BODY. TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. PRIOR TO NOTING THE CARDIAC TAMPONADE, ABLATION HAD NOT BEEN PERFORMED. NO STEAM POP. THE EVENT OCCURRED DURING THE MAPPING PHASE OF RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528970 SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439011 E8313885 10846835008852

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Life Threatening| H| R CARTO 3 SYSTEM| PENTARAY NAV ECO 7FR, D, 2-6-2| CARTO 3 SYSTEM| PENTARAY NAV ECO 7FR, D, 2-6-2