BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 16788658 · Received April 21, 2023

    Report

    Report Number
    2029046-2023-00870
    Event Type
    Death
    Date Received
    April 21, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 21, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER PHONE: (B)(6). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30980332L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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. 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 PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER. THE PATIENT SUFFERED CARDIAC ARREST AND ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT CARDIAC ARREST OCCURRED MID CASE. TOE SHOWED NO PERICARDIAL EFFUSION/PERFORATION. THE FOLLOWING THINGS OCCURRED: THE PATIENT LOST OUTPUT, CPR, MER (MEDICAL EMERGENCY RESUSCITATION) TEAM, ICU, CARDIOTHORACIC INVOLVEMENT. UNFORTUNATELY, THE DECISION WAS MADE TO CEASE ATTEMPTS TO RESUSCITATE PATIENT. AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) IN SITU. PREVIOUS ABLATIONS FOR AFIB AND TYPICAL FLUTTER. MANY COMORBIDITIES. ADDITIONAL INFORMATION- THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. THE EVENT OCCURRED MID CASE SO WHILST USING BW PRODUCTS. PHYSICIAN DOES NOT BELIEVE THE BW PRODUCTS USED WERE DIRECTLY INVOLVED IN THE ADVERSE EVENT. INTERVENTION PROVIDED WAS CPR, MER TEAM, CARDIAC ANGIOGRAPHY, TOE (TRANSOESOPHAGEAL ECHOCARDIOGRAPHY), ICU REVIEW, CARDIOTHORACIC SURGEON REVIEW. GENERATOR INFORMATION WAS A SMARTABLATE GENERATOR; G4C-2644. THE PHYSICIAN USED GRAPH VIEWER, DASHBOARD FORCE VALUE, VISITAG WITH SURPOINT DATA DISPLAYED, AND VECTOR WITH A MAXIMUM WARNING OF 40G WHICH RESULTS IN RED FLASHING BACKGROUND IF EXCEEDED. PARAMETERS FOR STABILITY FOR THE VISITAG MODULE USED WAS MAXIMUM DISTANCE CHANGE 3MM, MINIMUM TIME 3 SEC, FORCE OVER TIME 25%, MINIMUM FORCE 3G, ALSO WAS RESPIRATORY GATED. USES SURPOINT DATA OF 450-500 ANTERIORLY AND 350-400 POSTERIORLY. ADDITIONAL FILTER USED WITH THE VISITAG WAS THE SURPOINT DATA. TAG INDEX WAS ALSO USED. BWI CLINICAL UNDERSTANDING OF THE COMPLIANT WAS THAT PATIENT EXPIRED. ALL DEATHS WERE BWI. FDA APPROVED ¿ CE MARK DEVICES ARE INVOLVED ARE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668516 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC D134805 30980332L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Life Threatening| R| D CARTO 3 EXTERNAL REF PATCH| CARTO 3 SYSTEM| CARTO VISITAG MODULE| PENTARAY NAV| SMARTABLATE GENERATOR| VIZIGO SHEATH| WEBSTER CS CATHETER