BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 24656005 · Received March 20, 2026

    Report

    Report Number
    2029046-2026-00937
    Event Type
    Death
    Date Received
    March 20, 2026
    Date of Event
    February 27, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 24-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE FOLLOWING WEEK, AROUND (B)(6) 2026, THE PATIENT HAD MADE IT OUT OF SURGERY AND WAS DOING WELL AT RECOVERY. HOWEVER, THE SAME WEEK THE PATIENT HAD MULTIPLE SURGERIES AND WAS IN THE HOSPITAL. IT WAS EVENTUALLY REPORTED THAT THE PATIENT PASSED AWAY. FURTHER DETAILS INCLUDING THE DATE OF DEATH IS UNKNOWN. NOTE: DATE OF DEATH WAS POPULATED AS (B)(6) 2026 AS A BEST GUESS DATE OF DEATH. CORRECTION: IT WAS NOTICED THE INCORRECT PRODUCT WAS REPORTED IN THE 3500A INITIAL MEDWATCH REPORT. THE PRODUCT CATALOG HAS NOW BEEN UPDATED FROM ¿UNK_THERMOCOOL SF NAV¿ TO ¿UNK_SMART TOUCH UNIDIRECTIONAL SF¿ IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, 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. NOTE : FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SF NAV (STSF)CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. HOWEVER, THE PERICARDIAL EFFUSION CONTINUED TO GROW LARGER, AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY TO UNDERGO SURGERY. THE PATIENT¿S STATUS WAS IMPROVED. IT WAS INITIALLY REPORTED THAT AT THE BEGINNING OF THE CASE, UPON CONNECTION OF THE QDOT CATHETER, THE TX ECO CABLE STARTED BLINKING RED AND AN "ECO DONGLE TEST FAIL ERROR" (UNKNOWN ERROR CODE) WAS DISPLAYED ON THE CARTO 3 SYSTEM. THE CATHETER CONNECTIONS WERE RESEATED 2 OR 3 TIMES WITHOUT RESOLUTION. THE QDOT CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE QDOT CATHETER WAS REPLACED WITH AN STSF CATHETER, BYPASSING THE TX ECO CABLE, AND THERE WERE NO ERRORS DISPLAYED ON THE CARTO 3 SYSTEM. THE PROCEDURE CONTINUED. ONE OF THE QDOT CABLES WAS BRAND NEW AND THE QDOT CATHETER WAS BRAND NEW. THE CUSTOMER'S REPORTED CONNECTION RECOGNITION ISSUES ARE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. THEN, IT WAS REPORTED THAT AFTER THE ABLATION WAS COMPLETED AND THE CATHETERS WERE REMOVED FROM THE PATIENT¿S BODY, THE PATIENT HAD A PERICARDIAL EFFUSION. THE PHYSICIAN PERFORMED A POST-PROCEDURE CHECK FOR EFFUSIONS USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND A SMALL PERICARDIAL EFFUSION WAS NOTICED AND CONFIRMED. AT THAT POINT, THE PATIENT'S BLOOD PRESSURE WAS STABLE THE ENTIRE TIME. THE PHYSICIAN PERFORMED PERICARDIOCENTESIS TO DRAIN THE PERICARDIAL EFFUSION, AND AS PERICARDIOCENTESIS WAS BEING PERFORMED, THE PERICARDIAL EFFUSION CONTINUED TO GROW LARGER. THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY ABOUT 2 HOURS LATER TO UNDERGO SURGERY, AND UNABLE TO PROVIDE DETAILS REGARDING THE PROCEDURE BEING PERFORMED. THE LAST KNOWN PATIENT STATUS WAS STABLE. ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THAT THE PERFORATION WAS NEAR THE RIGHT INFERIOR PULMONARY VEIN/CARINA. DURING THE PERICARDIOCENTESIS PERFORMED IN THE LAB, THE BLOOD CONTINUED TO BE DRAINED AND PARTIALLY GIVEN BACK TO THE PATIENT FOR AROUND 2 HOURS. THE PATIENT WAS THEN TRANSPORTED TO A LARGER FACILITY WHERE THEY UNDERWENT SURGERY. THE OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE PATIENT NEEDED EXTENDED HOSPITALIZATION BECAUSE OF SURGERY AND IS RECOVERING IN THE HOSPITAL. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE WITH BRK-1 NEEDLE. THE CATHETERS WERE EXCHANGED TWICE. THE NUMBER OF PERFORMED ABLATIONS WAS 87. NO EVIDENCE OF STEAM POP. THE FLOW SETTING WAS STANDARD DEFAULT SETTINGS: 2 STANDBY FLOW AND THEN 8/15ML/MIN. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THE VISITAG MODULE PARAMETERS FOR STABILITY USED WERE TIME: 3 SEC, FORCE OVER TIME: 25% AND MINIMUM FORCE 3G. THE COLOR OPTION USED PROSPECTIVELY WAS OTHER-IMPEDANCE DROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327367 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| H| D| R