BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21831906 · Received April 11, 2025

    Report

    Report Number
    2029046-2025-01133
    Event Type
    Death
    Date Received
    April 11, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 23-APR-2025. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE CAUSE OF DEATH WAS CARDIOVASCULAR RELATED DUE TO THE PREVIOUS STROKE, AS WELL AS MITRAL AND TRICUSPID VALVE REGURGITATION. THE PHYSICIAN DID NOT THINK IT WAS ANYTHING RELATED TO BIOSENSE WEBSTER INC. (BWI) PRODUCTS. THE PATIENT HAD MULTIPLE HEALTH COMPLICATIONS. IT WAS ALSO REPORTED THAT THE LOT NUMBER FOR THE PRODUCT IS NOT AVAILABLE BECAUSE THE CATHETER BOX WAS THROWN OUT. 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

    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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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 DURING THE DIAGNOSTIC PORTION OF AN ATRIAL FLUTTER ABLATION PROCEDURE, THE PATIENT EXPERIENCED ARRHYTHMIAS AND EXPIRED. DURING ENTRAINMENT WITH ABLATION CATHETER, THE PHYSICIAN CAME OFF PACING AND THE PATIENT WAS IN AN UNKNOWN RHYTHM. ALSO, THEY SAW MULTIPLE FLUTTER WAVES AND A DISASSOCIATED QRS WAVES. THE PHYSICIAN PUT THE CATHETER IN THE VENTRICLE AND TRIED PACING FROM THE VENTRICLE WITH THE CATHETER. DURING THE EVENT, THE PATIENT WAS IN PULSELESS ELECTRICAL ACTIVITY (PEA). THE RHYTHM SIMULATED VENTRICULAR ESCAPE, AND THE PATIENT FLAT-LINED. THEY ATTEMPTED TO SHOCK THE PATIENT TWO TIMES AND CHEST COMPRESSIONS STARTED. COMPRESSIONS WERE CONDUCTED FOR OVER 40 MINUTES, AND ULTIMATELY, THE PATIENT EXPIRED. THE PATIENT WAS IN FLUTTER RHYTHM OF 2 TO 1 AND 3 TO 1. DURING ADVANCEMENT OF THE CATHETERS, THE PATIENT CONTINUED TO BE IN FLUTTER. ONE CATHETER (DECANAV) PLACED INTO THE CORONARY SINUS AND THE ABLATION CATHETER (THERMOCOOL SMARTTOUCH) PLACED IN THE CAVO-TRICUSPID ISTHMUS (CTI) LINE. NO ABLATION OR ANY ELECTRICAL MAPPING DONE DURING THIS CASE. THE NIGHT PRIOR TO THE PROCEDURE, THE PATIENT SUFFERED A STROKE, BUT THE PATIENT WAS CLEARED AFTER CONFIRMATION WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE PATIENT HAD MITRAL VALVE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091378 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D| L CARTO 3 SYSTEM| DECANAV® CATHETER