BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 9684653 · Received February 7, 2020

    Report

    Report Number
    2029046-2020-00203
    Event Type
    Death
    Date Received
    February 7, 2020
    Date of Event
    January 13, 2020
    Report Date
    May 5, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 5/5/2020, IT WAS NOTICED THAT THE MANUFACTURE DATE AND EXPIRATION DATE WERE OMITTED IN ERROR. SECTION D4 EXPIRATION DATE HAS BEEN UPDATED WITH 9/17/2020 AND SECTION H4 MANUFACTURE DATE HAS BEEN UPDATED WITH 9/18/2019. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED. THEREFORE, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE IDENTIFIED. NO CODE AVAILABLE TO REPRESENT SURGICAL INTERVENTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE (REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION), CARDIAC ARREST (REQUIRING CARDIOPULMONARY RESUSCITATION (CPR)) AND DEATH. AT AN UNSPECIFIED STAGE DURING THE PROCEDURE, BLEEDING WAS NOTICED AND CARDIAC TAMPONADE WAS CONFIRMED. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE FLUID FROM THE PERICARDIAL SPACE. THE PATIENT WAS THEN TAKEN TO SURGERY FOR A STERNOTOMY TO REPAIR THE WOUND. THE PATIENT WENT INTO CARDIAC ARREST. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS ATTEMPTED. HOWEVER, IT WAS NOT POSSIBLE TO BE APPLIED. CPR WAS PERFORMED FOR 1.5 HOURS WITHOUT SUCCESS AND THE PATIENT EXPIRED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST JUDE MEDICAL BRK XS NEEDLE. SETTINGS FOR VISUALIZATION INCLUDE: GRAPH, DASHBOARD, VECTOR, AND VISITAG. STABILITY PARAMETERS USED WERE ARRANGE OF 2.5 MM, TIME OF 3 SEC, FORCE OVER TIME OF 3G AT 25%, TAG SIZE OF 3, AND A RESPIRATION FILTER WAS USED. IRRIGATED CATHETER SETTINGS WERE SET TO 2ML CURRENT FLOW AND 8/15ML DURING ABLATION. NO BIOSENSE WEBSTER INC. (BWI) PRODUCT MALFUNCTIONS WERE REPORTED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS PATIENT CONDITION AND PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143208 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30290069L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R CARTO 3 SYSTEM.| ST JUDE MEDICAL BRK XS NEEDLE.