BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 25295560 · Received May 26, 2026

    Report

    Report Number
    2029046-2026-01672
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION DETAILS. THE DEVICE WAS RETURNED TO JOHNSON AND JOHNSON MEDTECH FOR EVALUATION ON 20-MAY-2026. VISUAL INSPECTION, TEMPERATURE AND IMPEDANCE TEST, AND PUMP AND PRESSURE GAGE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING JOHNSON AND JOHNSON MEDTECH PROCEDURES. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS IRRIGATING CORRECTLY, NO OBSTRUCTED HOLES WERE OBSERVED. NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE CATHETER INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: WHEN RF ENERGY IS INTERRUPTED FOR EITHER A TEMPERATURE OR AN IMPEDANCE RISE (THE SET LIMIT IS EXCEEDED), THE CATHETER SHOULD BE REMOVED, AND THE TIP CLEANED OF COAGULUM, IF PRESENT. AS PART OF JOHNSON AND JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH CATHETER AND OBSERVED AN IRRIGATION ISSUE (DEVICE WAS USED IN THE PATIENT). THE CATHETER DOES NOT FLUSH THE IRRIGATION. THEY TRIED TO FLUSH AND REPLACE THE CATHETER. THE PROCEDURE WAS DELAYED 5 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 04-MAY-2026. THE DEVICE WAS USED IN THE PATIENT. WHEN THEY OPENED THE CATHETER AND TRIED THE FIRST FLUSH, THEY DID NOT NOTICE ANYTHING. THE ISSUE WAS DISCOVERED WHEN THEY TRIED TO START TO ABLATE. THE GENERATOR WAS A SMARTABLATE WITH THE ASSOCIATED PUMP. THE SETTINGS WERE CORRECT FOR THE CATHETER. NO FLOW RATE ISSUE. THE PUMP WORKED ON 2 ML/M AND THEN WENT TO 30 ML/M IN ABLATION. THERE WAS NO ERROR. THE ISSUE WAS DISCOVERED BY STARTING THE ABLATION. THE TEMPERATURE JUMPED TO HIGH AND THE ABLATION WAS STOPPED BY THE GENERATOR. THEY TRIED TO FLUSH THE CATHETER OUTSIDE THE PATIENT AND THEY SAW THAT IT FLUSHED TOO SLOW. THE IRRIGATION ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 04-MAY-2026 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 04-MAY-2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579400 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31853033M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown