BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION

    MDR report key: 17967512 · Received October 19, 2023

    Report

    Report Number
    2029046-2023-02379
    Event Type
    Injury
    Date Received
    October 19, 2023
    Date of Event
    September 25, 2023
    Report Date
    November 16, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER ADDRESS LINE 1 (CONT.): (B)(6) RECEIVING DOCK. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2023. THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2023. A PATIENT RECEIVING AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE INVOLVING A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED A CARDIAC PERFORATION AND REQUIRED A PERICARDIOCENTESIS WITH ALMOST 1.5 LITERS OF FLUID REMOVED, TRANSFUSION, AND EXTENDED HOSPITALIZATION. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT A PERFORATION OF THE LEFT ATRIAL APPENDAGE AND PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TOWARDS THE END OF THE CASE BECAUSE THE PATIENT'S BLOOD PRESSURE HAD DROPPED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. THERE WAS NO EVIDENCE OF STEAM POP. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BOSTON SCIENTIFIC VERSACROSS RF WIRE. CORRECT SETTINGS AND PARAMETERS WERE UTILIZED ON DEVICES. NO ERROR MESSAGES WERE OBSERVED DURING THE PROCEDURE. PATIENT'S OUTCOME IS FULLY RECOVERED (NO RESIDUAL EFFECTS). DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 31119527L, AND NO NON-CONFORMANCES WERE IDENTIFIED. BASED ON THE COMPLETED MRE, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED WITH APPROPRIATE INFORMATION. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE PHYSICIAN'S OPINION IS THE CAUSE IS THE PROCEDURE AND THE PATIENT CONDITION. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A PATIENT RECEIVING AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE INVOLVING A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND EXPERIENCED A CARDIAC PERFORATION AND REQUIRED A PERICARDIOCENTESIS WITH ALMOST 1.5 LITERS OF FLUID REMOVED, TRANSFUSION, AND EXTENDED HOSPITALIZATION. IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT A PERFORATION OF THE LEFT ATRIAL APPENDAGE AND PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TOWARDS THE END OF THE CASE BECAUSE THE PATIENT'S BLOOD PRESSURE HAD DROPPED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT CONDITION RELATED. THERE WAS NO EVIDENCE OF STEAM POP. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BOSTON SCIENTIFIC VERSACROSS RF WIRE. CORRECT SETTINGS AND PARAMETERS WERE UTILIZED ON DEVICES. NO ERROR MESSAGES WERE OBSERVED DURING THE PROCEDURE. PATIENT'S OUTCOME IS FULLY RECOVERED (NO RESIDUAL EFFECTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2078100 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31119527L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| R BOSTON SCIENTIFIC VERSACROSS RF WIRE.| SMARTABLATE GENERATOR KIT-US.| SMARTABLATE PUMP KIT-US.