BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 12401679 · Received August 31, 2021

    Report

    Report Number
    2029046-2021-01467
    Event Type
    Death
    Date Received
    August 31, 2021
    Date of Event
    August 6, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 65-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED VENTRICULAR TACHYCARDIA (VT), CARDIAC TAMPONADE(CT), REQUIRING ATTEMPTED PERICARDIOCENTESIS, SURGICAL INTERVENTION AND DEATH. AFTER ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI) LINE IN THE RIGHT ATRIUM, DURING POST-ABLATION EP STUDY (POST-ABLATION PACING), THE PATIENT BECAME HYPOTENSIVE. AFTER PACING WAS COMPLETED, THE PATIENT WAS NOTED TO BE HYPOTENSIVE AND HAD A COLOR CHANGE. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING VIA A SOUNDSTAR CATHETER WAS INSERTED AND DEMONSTRATED A PERICARDIAL EFFUSION. IT WAS AT THAT TIME THAT THE PATIENT WENT INTO PULSELESS VENTRICULAR TACHYCARDIA. RESUSCITATION EFFORTS WERE STARTED, INCLUDING MULTIPLE EXTERNAL DEFIBRILLATION ATTEMPTS. A PERICARDIOCENTESIS WAS ATTEMPTED BUT NOT SUCCESSFUL. A CARDIOTHORACIC SURGERY (CT) WAS PERFORMED, AND A PERICARDIAL WINDOW WAS PLACED. THE PATIENT WAS PRONOUNCED DEAD AFTER 30 MINUTES OF RESUSCITATION. NO REPORT OF SITE OF PERFORATION BUT THE PHYSICIAN BELIEVES, GIVEN THE SIZE OF THE EFFUSION, THAT IT WAS AT THE RV WHEN THE ABLATION CATHETER WAS PLACED THERE FOR PACING. THE PHYSICIAN BELIEVES THAT WHEN THE ABLATION CATHETER WAS ADVANCED INTO THE RIGHT VENTRICLE FOR POST-ABLATION PACING, A PERFORATION MAY HAVE OCCURRED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER, INC. (BWI) FOR EVALUATION AND A VISUAL INSPECTION, AS WELL AS AN EVALUATION OF ALL FEATURES OF THE CATHETER WERE CONDUCTED. VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. PER THE EVENT, SEVERAL TESTS WERE PERFORMED. THE MAGNETIC, TEMPERATURE AND FORCE FEATURES WERE TESTED AND NO ISSUES WERE OBSERVED. IN ADDITION, THE PRODUCT WAS DEFLECTING AND IRRIGATING CORRECTLY. NO MALFUNCTIONS WERE OBSERVED DURING THE PRODUCT ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30567846L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE INSTRUCTIONS FOR USE STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FLUTTER RIGHT (R-AFL) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED VENTRICULAR TACHYCARDIA (VT), CARDIAC TAMPONADE(CT), REQUIRING ATTEMPTED PERICARDIOCENTESIS, SURGICAL INTERVENTION AND DEATH. AFTER ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI) LINE IN THE RIGHT ATRIUM, DURING POST-ABLATION EP STUDY (POST-ABLATION PACING), THE PATIENT BECAME HYPOTENSIVE. AFTER PACING WAS COMPLETED, THE PATIENT WAS NOTED TO BE HYPOTENSIVE AND HAD A COLOR CHANGE. AN INTRACARDIAC ECHOCARDIOGRAPHY (ICE) IMAGING VIA A SOUNDSTAR CATHETER WAS INSERTED AND DEMONSTRATED A PERICARDIAL EFFUSION. IT WAS AT THAT TIME THAT THE PATIENT WENT INTO PULSELESS VENTRICULAR TACHYCARDIA. RESUSCITATION EFFORTS WERE STARTED, INCLUDING MULTIPLE EXTERNAL DEFIBRILLATION ATTEMPTS. A PERICARDIOCENTESIS WAS ATTEMPTED BUT NOT SUCCESSFUL. A CARDIOTHORACIC SURGERY (CT) WAS PERFORMED, AND A PERICARDIAL WINDOW WAS PLACED. THE PATIENT WAS PRONOUNCED DEAD AFTER 30 MINUTES OF RESUSCITATION. NO REPORT OF SITE OF PERFORATION BUT THE PHYSICIAN BELIEVES, GIVEN THE SIZE OF THE EFFUSION, THAT IT WAS AT THE RV WHEN THE ABLATION CATHETER WAS PLACED THERE FOR PACING. THE PHYSICIAN BELIEVES THAT WHEN THE ABLATION CATHETER WAS ADVANCED INTO THE RIGHT VENTRICLE FOR POST-ABLATION PACING, A PERFORATION MAY HAVE OCCURRED. A TRANSSEPTAL PUNCTURE WAS NOT PERFORMED. PRIOR TO NOTING THE CT, ABLATION WAS PERFORMED. EARLIER IN THE CASE, THE PHYSICIAN FELT THERE MAY HAVE BEEN A STEAM POP, BUT THERE WAS NO NOTED IMPEDANCE RISE ON THE CATHETER DURING ABLATION, AND NO AUDIBLE POP BY THE TEAM MEMBERS. IRRIGATED CATHETER FLOW SETTINGS WERE 8/15 ML. NO ERROR MESSAGES WERE OBSERVED ON THE BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. FORCE VISUALIZATION USED WERE: GRAPH, DASHBOARD, VECTOR & VISITAG WITH THE VISITAG MODULE PARAMETERS FOR STABILITY AT: 2.5MM, 5 SECS, 25% AND TAG INDEX FOR COLOR OPTION. THERE WAS NO EVIDENCE OF ANY EFFUSION PRESENT BEFORE THE PROCEDURE. MAX WATTAGE USED: 45W. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290601 THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30567846L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| L| R UNK_CARTO 3| UNK_SOUNDSTAR| UNK_CARTO 3| UNK_SOUNDSTAR