BEUDAMED
    FDA Adverse Event Death Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 19621260 · Received June 26, 2024

    Report

    Report Number
    2029046-2024-02115
    Event Type
    Death
    Date Received
    June 26, 2024
    Date of Event
    May 17, 2024
    Report Date
    July 22, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835009972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON 08-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CASE WAS MAPPED WITH A PENTARAY¿ CATHETER AND ABLATED WITH BOSTON SCIENTIFIC FARAWAVE¿ CATHETER AND A FARADRIVE¿ SHEATH WAS USED. THE PATIENT HAD BEEN WELL, AND ALL HIS VITALS WERE PERFECTLY NORMAL UNTIL SATURDAY ((B)(6) 2024) LATE MORNING, WHEN HE FIRST COMPLAINED ABOUT DISCOMFORT. A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED BUT THE PATIENT RAPIDLY DECLINED AND DIED EVEN THOUGH HE HAD IMMEDIATE ASSISTANCE AND A CONSULTANT PRESENT. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE MOST SUSPECTED DEVICE ATTRIBUTED TO THE DEATH IS THE BOSTON SCIENTIFIC FARAWAVE¿ CATHETER, SINCE THE ABLATION CATHETER DELIVERS ENERGY VIA DIRECT CONTACT WITH CARDIAC TISSUE. THERE WERE NO REPORTED MALFUNCTIONS WITH THE BIOSENSE WEBSTER INC. (BWI) CATHETERS THAT WERE INVOLVED IN THE CASE. THEREFORE, H6. HEALTH EFFECT - CLINICAL CODE, H6. HEALTH EFFECT - IMPACT CODE, AND H6. MEDICAL DEVICE PROBLEM CODE HAVE BEEN UPDATED. WITH THE AVAILABLE INFORMATION, THE BWI PRODUCT IS TO BE CONSIDERED A CONCOMITANT DEVICE IN THIS EVENT AND NO LONGER CONSIDERED TO BE MDR REPORTABLE AGAINST THE BWI WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY. SHOULD MORE INFORMATION BECOME AVAILABLE IN THE FUTURE, THE REPORTABILITY DECISION WILL BE REASSESSED. 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

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT DIED. AFTER A PULMONARY VEIN ISOLATION (PVI) ON THE (B)(6), THE PATIENT LEFT FINE. THE NEXT DAY, AT 2PM THE PATIENT DIED. AT THE TIME OF REPORTING, THE CAUSE OF DEATH IS UNKNOWN AND AN AUTOPSY WAS ONGOING. IT HAS BEEN MENTIONED THAT THE ABLATION WAS DONE WITH A FARAPULSE AND DRIVE CATHETERS, AND A WEBSTER CORONARY SINUS (CS) CATHETER. SINCE THE CAUSE OF DEATH IS UNKNOWN AND DETAILS ABOUT THE PROCEDURE IS VERY LIMITED, WE CANNOT EXCLUDE BIOSENSE WEBSTER INC. (BWI) CATHETER AS A CONTRIBUTING FACTOR. ADDITIONAL INFORMATION IS BEING REQUESTED FOR CLARIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102213 WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 10846835009972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death CARTO 3 SYSTEM| UNKNOWN DRIVE CATHETER| UNKNOWN FARA PULSE CATHETER