BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR ECO GE 8F CATHETER

    MDR report key: 9121708 · Received September 26, 2019

    Report

    Report Number
    2029046-2019-03695
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    OBJ
    UDI-DI
    10846835008869
    PMA / PMN Number
    K140318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A MALE (102.2KG) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AF) WITH A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AROUND 300CC OF FLUID. THE PATIENT¿S CONDITION REPORTEDLY IMPROVED AS THE BLOOD PRESSURE NORMALIZED AND PATIENT WAS STABLE. PHYSICIAN'S OPINION IS THAT THE EFFUSION WAS POSSIBLY CAUSED BY THE SHEATH. THE MODEL OF THE SHEATH USED IS UNKNOWN. NO BIOSENSE WEBSTER INC. (BWI) PRODUCT MALFUNCTIONS WERE REPORTED. THERE WERE NO ERROR MESSAGES ON ANY BWI EQUIPMENT. HOWEVER, SINCE IT IS NOT POSSIBLE TO CONFIRM THAT THE EFFUSION WAS CAUSED BY THE SHEATH OR ONE OF THE 3 BWI CATHETERS, THIS EVENT WILL BE CONSERVATIVELY REPORTED UNDER ALL THREE DIAGNOSTIC CATHETERS. DEVICE EVALUATION INVESTIGATION: THE DEVICE INVESTIGATION HAS BEEN COMPLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE MANUFACTURED DATE HAS BEEN PROVIDED. THEREFORE, DEVICE MANUFACTURE DATE HAS BEEN POPULATED. 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 PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. STILL PENDING IS THE MANUFACTURER RECORD EVALUATION AND MANUFACTURED DATE. THEREFORE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS THREE REPORTS RELATED TO THE SAME EVENT: MFR # 2029046-2019-03695 FOR THE SOUND STAR ECO 8FG ULTRASOUND CATHETER, MFR # 2029046-2019-03696 FOR THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY, MFR # 2029046-2019-03697 FOR THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID (QUADRAPOLAR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE (102.2 KG) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AF) WITH A SOUND STAR ECO 8FG ULTRASOUND CATHETER, A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND A WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE MAPPING PHASE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED BEFORE ABLATING. THE SOUND STAR ECO 8FG ULTRASOUND CATHETER, THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID (QUADRAPOLAR) WERE THE ONLY CATHETERS IN THE BODY. THE PERICARDIAL EFFUSION WAS CONFIRMED BY ECHO. PERICARDIOCENTESIS WAS PERFORMED TO REMOVE AROUND 300CC OF FLUID. THE PATIENT¿S CONDITION REPORTEDLY IMPROVED AS THE BLOOD PRESSURE NORMALIZED AND PATIENT WAS STABLE. PHYSICIAN'S OPINION IS THAT THE EFFUSION WAS POSSIBLY CAUSED BY THE SHEATH. THE MODEL OF THE SHEATH USED IS UNKNOWN. NO BIOSENSE WEBSTER INC. (BWI) PRODUCT MALFUNCTIONS WERE REPORTED. THERE WERE NO ERROR MESSAGES ON ANY BWI EQUIPMENT. HOWEVER, SINCE IT IS NOT POSSIBLE TO CONFIRM THAT THE EFFUSION WAS CAUSED BY THE SHEATH OR ONE OF THE 3 BWI CATHETERS, THIS EVENT WILL BE CONSERVATIVELY REPORTED UNDER ALL THREE DIAGNOSTIC CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916679 SOUNDSTAR ECO GE 8F CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC. G9108167 10846835008869

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R