BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    MDR report key: 9121719 · Received September 26, 2019

    Report

    Report Number
    2029046-2019-03697
    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
    LDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE MANUFACTURING RECORD EVALUATION COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS THREE REPORTS RELATED TO THE SAME EVENT: MFR # 2029046-2019-03695 FOR THE SOUNDSTAR 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 (QUADRIPOLAR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE ((B)(6) KG) 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. DURING THE MAPPING PHASE, A PERICARDIAL EFFUSION WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED BEFORE ABLATING. THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, THE WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE WEBSTER¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID (QUADRIPOLAR) 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
    915784 WEBSTER ELECTROPHYSIOLOGY CATHETER WITH AUTO ID ELECTRODE, PACEMAKER, TEMPORARY LDF BIOSENSE WEBSTER INC.

    Patients

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