BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15984905 · Received December 15, 2022

    Report

    Report Number
    2029046-2022-03132
    Event Type
    Death
    Date Received
    December 15, 2022
    Date of Event
    November 15, 2022
    Report Date
    December 14, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. SECTION H3. HAS BEEN UPDATED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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

    IT WAS REPORTED THAT A 78-YEAR-OLD FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CEREBROVASCULAR ACCIDENT AND THE PATIENT EXPIRED. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT A BRAIN BLEED WAS DISCOVERED FOLLOWING AN A-FIB PROCEDURE. THE PATIENT DID NOT WAKE UP FROM ANESTHESIA WHILE IN RECOVERY. THE CODE NEURO WAS CALLED IN AND PERFORMED A FULL EVALUATION. THE EXTENSIVE BRAIN BLEEDING WAS DISCOVERED AFTER SCANS WERE PERFORMED. NO MEDICAL INTERVENTION WAS BEING PROVIDED AND THAT SUPPORTIVE CARE WAS BEING PROVIDED UNTIL THE PATIENT EXPIRED. THE PHYSICIAN DID NOT BELIEVE THE BRAIN BLEED TO BE A RESULT OF THE PROCEDURE AND THAT THE PHYSICIAN BELIEVED THAT THE BRAIN BLEED OCCURRED PRIOR TO THE PROCEDURE. THE PHYSICIAN ALSO BELIEVED THAT THE PROCEDURE MAY HAVE ¿EXASPERATED¿ THE BRAIN BLEED. THE PATIENT HAD BEEN STABLE THROUGHOUT THE PROCEDURE AND HAD NO CONCERNS UNTIL THE PATIENT DID NOT WAKE UP FROM ANESTHESIA. THE ADVERSE EVENT OCCURRED ON (B)(6) 2022. DATE OF DEATH WAS NOTED TO BE (B)(6) 2022. ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF DEATH WAS FROM THE BLEED. HE BELIEVED A SMALL BLEED OCCURRED PRIOR TO PROCEDURE, THEN WAS EXACERBATED BY HEPARIN DURING PROCEDURE. RELEVANT TESTS/LABORATORY DATA-CT WAS PERFORMED TO CONFIRM BLEED. FORCE VISUALIZATION FEATURES USED WERE-GRAPH, DASHBOARD, VECTOR AND VISITAG. PARAMETERS FOR STABILITY FOR THE VISITAG MODULE USED WERE 2.5 MM, 3 SEC, 25% OVER 3 G. NO ADDITIONAL FILTER USED WITH THE VISITAG. COLOR OPTIONS USED PROSPECTIVELY WAS SURPOINT TAG INDEX. THERE WAS NO EVIDENCE OF CHAR DURING THE PROCEDURE. NO EVIDENCE OF BLOOD THROMBUS / CLOT DURING THE PROCEDURE. CARTO FILE NOT AVAILABLE. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. PUMP SWITCHING WAS FROM "LOW" TO "HIGH" FLOW DURING ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438973 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Life Threatening| D SMARTABLATE GENERATOR SPARE-US| UNK_CARTO 3