BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20782557 · Received November 26, 2024

    Report

    Report Number
    2029046-2024-03808
    Event Type
    Death
    Date Received
    November 26, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31384319L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION, HOWEVER THE PATIENT DIED. THE ATRIAL FIBRILLATION (AF) PROCEDURE WAS COMPLETED WITHOUT INITIAL COMPLICATIONS. HOWEVER, WHEN AF WAS FINISHED AND MOVED TO THE RIGHT ATRIUM, THE ABLATION CATHETER NO LONGER MARKED CONTACT FORCE. THE CATHETER WAS DISCONNECTED AND RECONNECTED FROM THE PATIENT INTERFACE UNIT (PIU) IN AN ATTEMPT TO RESOLVE THE PROBLEM, BUT IT PERSISTED. THE DOCTOR WAS NOTIFIED THREE TIMES OF THE WILLINGNESS TO REPLACE THE CATHETER; HOWEVER, THE DOCTOR PREFERRED TO CONTINUE WITHOUT REPLACEMENT AS IT WAS CLOSE TO COMPLETING THE PROCEDURE. DURING ABLATION IN THE CAVOTRICUSPID ISTHMUS, ADEQUATE IMPEDANCE DROPS WERE ACHIEVED. AT THE END OF ABLATION, IT WAS OBSERVED THAT THE PATIENT BEGAN TO DECOMPENSATE. AFTER A REVIEW WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE), A PERICARDIAL EFFUSION WAS IDENTIFIED. A PERICARDIAL PUNCTURE WAS IMMEDIATELY INITIATED TO DRAIN THE BLOOD WHILE COORDINATING THE AVAILABILITY OF A SURGEON AND AN OPERATING ROOM. IT WAS INFORMED THAT, WHEN SHE WAS TRANSFERRED TO THE OPERATING ROOM FOR OPEN HEART SURGERY, THE PATIENT SUFFERED A CARDIAC ARREST; THEY MANAGED TO RESUSCITATE HER ON THAT OCCASION, BUT SHE COULD NOT BE REVIVED AFTER A SECOND EPISODE OF CARDIAC ARREST. PATIENT DIED. IN SUBSEQUENT EXPLORATORY SURGERY, A PERFORATION OF APPROXIMATELY 5-7 CM WAS DETECTED, EXTENDING FROM THE RIGHT ATRIUM TO THE VENA CAVA. THE DOCTOR SUSPECTS THAT THE PERFORATION MIGHT HAVE BEEN CAUSED BY THE DEFLECTABLE SHEATH THEY USED, WHICH WAS AN AGILIS. THE CONTACT FORCE ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2404922 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31384319L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| D AGILIS SHEATH| SMARTABLATE PUMP KIT-WW| UNK_CARTO 3| UNK_SMARTABLATE GENERATOR