BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19876162 · Received July 31, 2024

    Report

    Report Number
    2029046-2024-02561
    Event Type
    Death
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 15-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS DUE TO PATIENT CONDITION AND THE PROCEDURE ITSELF. THE PRECISE INTERVENTION THAT CREATED THE ADVERSE EVENT IS A PULMONARY VEIN ISOLATION USING POINT BY POINT ABLATIONS WITH RADIOFREQUENCY (RF) ENERGY. AS THE PATIENT HAD TO UNDERGO A RISKY PROCEDURE TO TRY AND SOLVE HIS LIFE-THREATENING ADVERSE EVENT, THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE PATIENT DIED AFTER A LONG STAY IN THE HOSPITAL. AS SUCH, FIELD H6. MEDICAL DEVICE PROBLEM CODE HAS BEEN UPDATED FROM THE A01 TO ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM (A24). FIELD H 6. HEALTH EFFECT - IMPACT CODE HAS BEEN UPDATED WITH ADDITIONAL CODES OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION (F08) AND DEATH (F02) NO ERROR MESSAGES WERE OBSERVED DURING THE PROCEDURE ACCORDING TO THE PHYSICIAN. 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 CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS 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. 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).

    Additional Manufacturer Narrative · 0

    ON 07-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE FISTULA WAS DISCOVERED ON THE FIRST OF (B)(6) 2024. THE REPORTER WAS ALERTED ON THE SECOND OF JULY. NO ESOPHAGEAL TEMPERATURE MONITORING WAS USED. 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 A PULMONARY VEIN ISOLATION (PVI) -PAROXYSMAL) PROCEDURE. THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT REQUIRED SURGICAL INTERVENTION. THE PROCEDURE TOOK PLACE ON THE (B)(6) 2024; HOWEVER, THE PATIENT CONTRACTED SYMPTOMS POST PROCEDURE ON THE (B)(6) 2024. NO SPECIFIC ISSUE HAPPENED DURING THE PROCEDURE. ON 06-JUN-2024, IT WAS REPORTED THAT THEY HAD NO MAIN ISSUE WITH THE CARTO AND/OR SMA SYSTEM (NO ERROR, ALERT AND/OR WARNING) DURING THE CASE. HOWEVER, THE PATIENT CONTRACTED SYMPTOMS POST PROCEDURE, 27 DAYS LATER. THE CASE HAS BEEN REVIEWED AND THE FORCE WAS NORMAL. THE POINT WAS BELOW THE ESOPHAGUS, AND THE VISITAG/ABLATION POINTS HAD A NORMAL ABLATION INDEX RECOMMENDATION. A FISTULA (HOLE) BETWEEN THE LEFT ATRIUM AND THE ESOPHAGUS HAS BEEN REPORTED. THE PATIENT IS STILL ALIVE, HAS BEEN OPERATED ON AND REPORTED TO BE STABLE ON THE (B)(6) 2024 AT 5:30 PM BELGIUM TIME. THE SURGEON TOOK A PART OF THE LEFT ATRIUM TO FILL UP THE FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983545 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R CARTO 3 SYSTEM| SMARTABLATE GENERATOR KIT-WW| SMARTABLATE PUMP KIT-WW