BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 23009252 · Received September 9, 2025

    Report

    Report Number
    2029046-2025-03068
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 11, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009811
    PMA / PMN Number
    P030031/S078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL INSPECTION, PUMP, AND PRESSURE GAUGE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. A PUMP AND PRESSURE GAUGE TEST WERE PERFORMED, AND THE DEVICE WAS IRRIGATED CORRECTLY. NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE IRRIGATION 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 INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: MAKE SURE THE IRRIGATION HOLES ARE NOT PLUGGED PRIOR TO RE-INSERTION; PURGE THE CATHETER AND THE IRRIGATION TUBING WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION OF THE CATHETER INTO THE PATIENT. AS PART OF JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMARTTOUCH SF APPROVED UNDER P030031/S078. 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 REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF CATHETER AND DURING THE OPERATION, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 13-AUG-2025. THE ISSUE WAS NOTED AFTER THE DEVICE WAS USED ON THE PATIENT. AFTER A PERIOD OF ABLATION, A BAG OF SALINE WAS REPLACED, THE SURGEON BRIEFLY STOPPED DISCHARGING, AND THEN TOOK OUT THE CATHETER TO PREPARE FOR RE-EVACUATION OF BUBBLES. HOWEVER, AFTER THE COMPLETION OF REPLACEMENT OF SALINE, IT WAS FOUND THAT THE BUBBLES COULD NOT BE DISCHARGED, AND THERE WAS NO DRIP IN THE DRIP CHAMBER OF THE IRRIGATION TUBE. AFTER STOPPING THE FORCED DRAINAGE, THE DRIP CHAMBER OF THE IRRIGATION TUBE WAS FILLED WITH LIQUID INSTEAD, CONSIDERING NEGATIVE PRESSURE. THE SYRINGE WAS USED TO FLUSH THE CATHETER, AND IT WAS FOUND THAT THE IRRIGATION WAS IMPOSSIBLE. CORRECT CATHETER SETTINGS SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE EVENT WAS REASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2803255 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31594375L 10846835009811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN GENERATOR| UNKNOWN IRRIGATION TUBE| UNKNOWN SYRINGE