BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPREME EP CATHETER 5F, QUADRIPOLAR, JSN

    MDR report key: 1440039 · Received August 5, 2009

    Report

    Report Number
    3005188751-2009-00040
    Event Type
    Injury
    Date Received
    August 5, 2009
    Date of Event
    July 30, 2009
    Report Date
    July 30, 2009
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS DISCARDED AT THE HOSPITAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. IT IS UNCERTAIN HOW THE PERFORATION OCCURRED. THE ST. JUDE MEDICAL INSTRUCTIONS FOR USE (IFU) STATE THAT THE RISKS OF USE OF ELECTROPHYSIOLOGY CATHETERS INCLUDE THOSE RISKS RELATED TO CARDIAC CATHETERIZATION IN GENERAL, SUCH AS CARDIAC PERFORATION AND TAMPONADE.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN ATRIAL FIBRILLATION ABLATION USING ENSITE NAVX WITH THE VELOCITY LMR. THE PATIENT WAS UNDER CONSCIOUS SEDATION FOR THIS PROCEDURE. THE PHYSICIAN PLACED A BOSTON SCIENTIFIC 20-POLE STEERABLE CATHETER (REF # 20SL2102, LOT # 12525737) INTO THE CORONARY SINUS (CS), A SJM 5F QUADRIPOLAR DIAGNOSTIC CATHETER (REF # 401443, LOT # 2792190) WAS PLACED IN THE RIGHT VENTRICULAR APEX (RVA), AND A BIOSENSE WEBSTER CELSIUS THERMO-COOL ABLATION CATHETER (REF # 35Q73R, LOT # 14011824) WAS PLACED THROUGH THE SJM AGILIS NXT (REF # 408309, LOT # 2794446) IN THE RIGHT ATRIUM (RA). ANALYSIS OF THE PATIENT'S RHYTHM DEMONSTRATED LEFT ATRIAL FIBRILLATION. A SIEMENS ACCUSON INTRA CARDIAC ULTRASOUND CATHETER (REF # 8267996) WAS PLACED IN THE RA TO GUIDE THE TRANSSEPTAL PUNCTURE. THE THERMO-COOL CATHETER WAS REMOVED AND TRANSSEPTAL PUNCTION WAS PERFORMED WITH A SJM BRK-1 NEEDLE (REF # 407207, LOT #2773087) USING THE AGILIS NXT AS THE PRIMARY TRANSSEPTAL GUIDING SHEATH. ACCORDING TO THE PHYSICIAN, THE TRANSSEPTAL PUNCTURE WENT SMOOTHLY AND LEFT ATRIAL (LA) ACCESS WAS CONFIRMED BY NOTING CAVITATION IN THE LA WHEN THE TRANSSEPTAL NEEDLE WAS FLUSHED. HEPARIN WAS ADMINISTERED AND THE ABLATION CATHETER WAS RE-INTRODUCED THROUGH THE AGILIS NXT INTO THE LA AND GEOMETRY OF FOUR PULMONARY VEINS, LEFT ATRIAL APPENDAGE (LAA) AND ATRIAL BODY WAS CREATED. ENSITE FUSION WAS USED TO FUSE A 3-D CT RECONSTRUCTION TO THE LA GEOMETRY. PULMONARY VEIN ISOLATION ABLATION WAS STARTED AND SEVERAL LESIONS WERE CREATED ALONG THE RIDGE BETWEEN THE LAA AND LEFT SUPERIOR PULMONARY VEIN (LSPV). THE PATIENT'S BLOOD PRESSURE BECAME SLIGHTLY UNSTABLE BUT IT WAS ASSOCIATED WITH DEEPER LEVELS OF SEDATION. THE CASE PROGRESSED FOR SEVERAL ADDITIONAL MINUTES AND LESIONS WERE PLACED ALONG THE POSTERIOR WALL. THE PHYSICIAN OBSERVED THE INTRACARDIAC ULTRASOUND IMAGE AND NOTED A SIGNIFICANT PERICARDIAL EFFUSION. THE ABLATION PROCEDURE WAS TERMINATED, CATHETERS WERE REMOVED FROM THE LA, AND ANTICOAGULATION WAS REVERSED. THE PHYSICIAN DECIDED TO PERFORM A PERICARDIOCENTESIS WHICH BROUGHT THE PATIENT'S BLOOD PRESSURE INTO A MORE HOMEOSTATIC RANGE. AFTER ONE LITER OF BLOOD WAS REMOVED, IT BECAME EVIDENT THAT THE DEFECT CAUSING THE PERICARDIAL EFFUSION WAS NOT RESOLVING AND THE PATIENT WAS TAKEN TO SURGERY. THE PHYSICIAN STATED THAT THE OR REPORTED THE PERFORATION WAS A RESULT OF THE DIAGNOSTIC RVA CATHETER PENETRATING THE RV APEX. THE SJM FCE WAS PRESENT DURING THE CASE. THE SJM 5F QUADRIPOLAR DIAGNOSTIC CATHETER (REF # 401443, LOT # 2792190) WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER 5F, QUADRIPOLAR, JSN SUPREME EP, 5F, JSN DRF ST. JUDE MEDICAL, AF DIVISION NA 2792190

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other HEPARIN