BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21608375 · Received March 14, 2025

    Report

    Report Number
    2029046-2025-00793
    Event Type
    Death
    Date Received
    March 14, 2025
    Date of Event
    February 17, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 15-APR-2025 INDICATED THAT THE PHYSICIAN¿S OPINION OF THE CAUSE OF DEATH WAS THERAPY-REFRACTORY COMBINED SEPTIC AND CARDIOGENIC SHOCK. AFTER THE PVI PROCEDURE, THE PATIENT DEVELOPED A CARDIAC TAMPONADE WHICH WAS TREATED BY PERICARDIOCENTESIS ON (B)(6) 2025. INITIALLY THE PATIENT FULLY RECOVERED, BUT SEVERAL HOURS LATER THE PATIENT¿S CONDITION WORSENED WITH POSITIVE SHOCK INDEX. EVENTUALLY, WE EXAMINED THE PATIENT ONCE AGAIN AND MADE ANOTHER PERICARDIOCENTESIS PERFORMED IN THE AFTERNOON. THE PATIENT¿S RESPIRATORY CONDITION ALSO WORSENED, SO THAT THE PATIENT HAD TO BE INTUBATED BY THE ANESTHESIOLOGISTS. AFTERWARDS THE PATIENT WENT INTO A SEPTIC AND CARDIOGENIC SHOCK AND DIED UNDER MAXIMAL INVASIVE MANAGEMENT AND MAXIMAL MEDICAL THERAPY SEVERAL HOURS LATER ON (B)(6) 2025, AFTER THE PATIENT WAS REANIMATED SEVERAL TIMES WITHOUT GETTING A RETURN OF SPONTANEOUS CIRCULATION (ROSC) FINALLY. THEREFORE, UPDATED THE B2. DATE OF DEATH FIELD. IN ADDITION, ADDED UNDER H6. HEALTH EFFECT - CLINICAL CODE FIELD ¿CARDIOGENIC SHOCK (E233601)¿ AND ¿SEPSIS (E0306)¿. 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 · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 OR PRODUCT ID NUMBERS ARE 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 PULMONARY VEIN ISOLATION (PVI) ABLATION WITH A THERMOCOOL SMARTTOUCH SF AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. PATIENT HAD A PERICARDIAL EFFUSION AFTER A CARTO CASE. SMARTABLATE POWER CONTROL 50 W WAS USED. ADDITIONAL INFORMATION WAS RECEIVED ON 03-MAR-2025. PUNCTURE OF THE CARDIAC TAMPONADE WAS PERFORMED FOR INTERVENTION. THE OUTCOME WAS DEATH. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAR-2025. NO MALFUNCTION REPORTED ON THE GENERATOR. ONE TRANSSEPTAL PUNCTURE SITE PERFORMED DURING THE PROCEDURE. PRIOR TO NOTING THE PERICARDIAL EFFUSION, ABLATION WAS PERFORMED. THE EVENT OCCURRED AFTER THE PATIENT WAS OUT OF THE LAB. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THE CATHETER SETTINGS SELECTED ON THE GENERATOR WERE 50 W/20 ML/MIN. ADDITIONAL INFORMATION WAS RECEIVED ON 12-MAR-2025. PHYSICIAN DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU) FOR FLOW RATE AND POWER, HE USED 20 ML/MIN. THE DURATION OF THE APPLICATION WITH 50 W WAS UNKNOWN AS THE PERICARDIAL EFFUSION WAS OBSERVED AFTER THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615309 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D BRK NEEDLE| SMARTABLATE GENERATOR KIT-WW| UNK CATHETER| UNK WEBSTER CS CATHETER| UNK_CARTO 3| UNK_CARTO VIZIGO SHEATH| UNK_OCTARAY NAV