BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 21268066 · Received January 29, 2025

    Report

    Report Number
    2029046-2025-00301
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 27, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF. AFTER PULMONARY VEIN ISOLATION (PVI) WAS COMPLETED, DURING ADDITIONAL ABLATION WAS BEING CONDUCTED, A TEMPERATURE RISE ALERT OCCURRED IN THE SMARTABLATE GENERATOR (SAG). WHEN CHECKED THE TIP OF THE ABLATION CATHETER, FOUND THAT THE IRRIGATION WAS NOT WORKING PROPERLY. TRIED TO FLUSH WITH THE SMARTABLATE PUMP (SAP) BUT COULD NOT FLOW SALINE SOLUTION FROM THE ABLATION CATHETER. AFTER REMOVING THE TUBE, TRIED FLUSHING THE ABLATION CATHETER WITH A SYRINGE, BUT CONFIRMED THAT SALINE SOLUTION DID NOT FLOW. THE ISSUE WAS RESOLVED BY REPLACING THE THERMOCOOL SMARTTOUCH SF CATHETER WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION ON 05-FEB-2025. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, PUMP, AND PRESSURE GAUGE TEST AND TEMPERATURE AND IMPEDANCE TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE WAS CONNECTED TO THE GENERATOR AND AN ABLATION CYCLE WAS PERFORMED AND THE DEVICE WAS FOUND WORKING CORRECTLY. NO TEMPERATURE OR IMPEDANCE ISSUES WERE OBSERVED. 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 HIGH TEMPERATURE AND IRRIGATION ISSUES REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USE OF THE DEVICE THAT MAY HAVE AFFECTED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: 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. WHEN CLEANING THE TIP ELECTRODE, BE CAREFUL NOT TO TWIST THE TIP ELECTRODE WITH RESPECT TO THE CATHETER SHAFT; TWISTING MAY DAMAGE THE TIP ELECTRODE BOND AND LOOSEN THE TIP ELECTRODE, OR MAY DAMAGE THE CONTACT FORCE SENSOR. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND THE IRRIGATION ISSUE DURING USE ON PATIENT ISSUE WAS OBSERVED. AFTER PULMONARY VEIN ISOLATION (PVI) WAS COMPLETED, DURING ADDITIONAL ABLATION WAS BEING CONDUCTED, A TEMPERATURE RISE ALERT OCCURRED IN THE SMARTABLATE GENERATOR (SAG). WHEN CHECKED THE TIP OF THE ABLATION CATHETER, FOUND THAT THE IRRIGATION WAS NOT WORKING PROPERLY. TRIED TO FLUSH WITH THE SMARTABLATE PUMP (SAP) BUT COULD NOT FLOW SALINE SOLUTION FROM THE ABLATION CATHETER. AFTER REMOVING THE TUBE, TRIED FLUSHING THE ABLATION CATHETER WITH A SYRINGE, BUT CONFIRMED THAT SALINE SOLUTION DID NOT FLOW. THE ISSUE WAS RESOLVED BY REPLACING THE THERMOCOOL SMARTTOUCH SF CATHETER WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. NO ERROR WAS NOTED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE TEMPERATURE RISE ALERT WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE IRRIGATION ISSUE DURING USE ON THE PATIENT WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758367 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31459791L 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SMARTABLATE PUMP KIT (JAPAN).| UNK_SMARTABLATE GENERATOR.