BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 11098767 · Received December 30, 2020

    Report

    Report Number
    3009498591-2020-00024
    Event Type
    Injury
    Date Received
    December 30, 2020
    Date of Event
    December 3, 2020
    Report Date
    March 16, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008852
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, THE DEVICE MANUFACTURER BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE PATIENT AND EVENT. SIEMENS WAS INFORMED ABOUT THE ADDITIONAL INFORMATION ON (B)(6) 2021. IT WAS REPORTED THE PATIENT WAS MALE. PATIENT'S CONDITION HAD IMPROVED. THERE'S NO REPORT THAT PROLONGED HOSPITALIZATION WAS REQUIRED. NO BWI PRODUCT MALFUNCTIONS NOR ERROR MESSAGES WERE REPORTED. THE PHYSICIAN IS UNSURE ABOUT THE CAUSE OF THE ADVERSE EVENT AND COMMENTED THIS WAS A CARDIAC RESYNCHRONIZATION THERAPY (CRT) PATIENT, THAT THE ATRIA WERE HYPERTROPHIED AND THAT THEY SUSPECTED INFERIOR VENA CAVA (IVC) DISSECTION. THEY ALSO COMMENTED THE ANATOMY OF THE IVC WAS COMPLICATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(64. THIS EVENT WAS ALSO REPORTED BY THE MANUFACTURER UNDER MDR #2029046-2020-02016 REFERENCE PM00262126

    Additional Manufacturer Narrative · 0

    THE AWARE DATE IN FIELD F6 OF THE INITIAL REPORT IS CORRECTED TO 12/04/2020. THIS EVENT WAS ALSO REPORTED BY THE MANUFACTURER UNDER MDR #2029046-2020-02016 REFERENCE: (B)(4).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    NO EVALUATION RESULTS ARE AVAILABLE AS THE DEVICE WAS NOT RETURNED. MANUFACTURER'S REF. # (B)(4). THIS EVENT WAS ALSO REPORTED BY THE MANUFACTURER UNDER MDR #2029046-2020-02016. REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. AFTER ACCESS SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER WAS INSERTED AND TRANSSEPTAL WAS PERFORMED (UNKNOWN DEVICE). BLOOD PRESSURE DROPPED FROM 110MMHG OF THE TIME OF ADMISSION TO 40MMHG. EFFUSION WAS CONFIRMED WITH INTRACARDIAC ECHO. THE PHYSICIAN DECIDED THAT ABLATION COULD NOT BE CONTINUED AND THE PROCEDURE WAS TERMINATED. PERICARDIOCENTESIS CONDUCTED. THE DRAINED BLOOD WAS VENOUS. THE PHYSICIAN'S COMMENTED THIS WAS A CARDIAC RESYNCHRONIZATION THERAPY (CRT) PATIENT, THAT THE ATRIA WERE HYPERTROPHIED AND THAT THEY SUSPECTED INFERIOR VENA CAVA (IVC) DISSECTION. THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER WAS NOT INSERTED INTO THE LEFT HEART SYSTEM, AND BEEAT AND SL LAMP X 2 [UNCLEAR] WERE INSIDE THE HEART IN ADDITION TO SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER WHEN CARDIAC TAMPONADE OCCURRED. THE PATIENT CONDITION WAS UNKNOWN AFTER THE PROCEDURE, BUT IT IS NOW STABLE. SEVERAL DEVICES WERE USED THAT MAY HAVE CONTRIBUTED TO THE EVENT INCLUDING THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND NON-BWI DEVICES. IN LIGHT OF THAT THE EVENT IS CONSERVATIVELY REPORTED UNDER THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558804 SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR, OBJ BIOSENSE WEBSTER INC 10439011 E8248117 10846835008852

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R BEEAT.| CARTO3 EXTERNAL REFPATCH 6PACK.| PENTARAY NAV ECO 7FR, D, 2-6-2.| SL LAMP.| SL LAMP.| SMARTABLATE IRR TUBE SET.| UNKNOWN TRANSSEPTAL DEVICE.