BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH

    MDR report key: 22462456 · Received July 9, 2025

    Report

    Report Number
    2029046-2025-02250
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 2, 2025
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION 09-JUL-2025. AS SUCH, SECTIONS D 9. DEVICE AVAILABLE FOR EVALUATION, D 9. DATE DEVICE RETURNED TO MANUFACTURER, AND D 9. IS DEVICE RETURNED TO MANUFACTURER HAVE BEEN UPDATED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND AT THE BEGINNING OF THE ABLATION PHASE AND THEREFORE AT HIGH FLOW, THE CATHETER DID NOT ALLOW ADEQUATE IRRIGATION (HIGH TEMPERATURE ON SMARTABLATE). ONCE THE ABLATOR WAS DISCONNECTED FROM THE STERILE EXTENSION, THE SALINE SOLUTION FROM THE SMARTABLATE TUBING (SAT) TO THE STERILE EXTENSION FLOWED NORMALLY. HOWEVER, AS SOON AS THE CATHETER WAS CONNECTED, THE FLOW WAS BLOCKED AS IF THERE WAS SOME MECHANICAL OBSTRUCTION INSIDE THAT PREVENTED THE FLOW FROM REACHING THE TIP OF THE CATHETER. CHANGING THE STERILE EXTENSION DID NOT SOLVE THE PROBLEM. INSTEAD, CHANGING THE CATHETER RESOLVED THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE ERROR ON THE PUMP WAS RELATED TO BUBBLES. SHORTLY AFTER THE START OF EACH RADIOFREQUENCY DELIVERY, THE BUBBLE ERROR APPEARED. THIS WAS LIKELY BECAUSE, AS THE PASSAGE WAS BLOCKED WITHIN THE ABLATOR, EXCESSIVE PRESSURE WAS GENERATED AT THE PUMP LEVEL. INITIALLY, THEY TRIED TO DO AN EXTERNAL WASH TO SEE IF THERE WERE BUBBLES AT THE LEVEL OF THE SAT. THEN, THEY CHANGED THE STERILE EXTENSION THAT CONNECTED THE SAT TO THE ABLATOR, AGAIN WITHOUT SUCCESS. THEY THEN REALIZED THAT THE PROBLEM WAS AT THE LEVEL OF THE ABLATOR, BECAUSE WHEN THEY PERFORMED THE WASH, THEY NOTICED THAT NO FLUID WAS COMING OUT OF THE CATHETER TIP, AS IF THERE WAS A MECHANICAL OBSTRUCTION INSIDE. REPLACING THE CATHETER RESOLVED THE ISSUE. THE HIGH TEMPERATURE AND BUBBLE ERROR ARE NOT MDR REPORTABLE. DEVICE INVESTIGATION DETAILS: FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION, IRRIGATION 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. AN IRRIGATION TEST WAS PERFORMED: THE DEVICE WAS CONNECTED TO THE PUMP AND IT WAS FLUSHING CORRECTLY. NO OBSTRUCTED HOLES, IRRIGATION OR SYSTEM ERRORS WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 31547913M, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE HIGH TEMPERATURE, BUBBLES 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 FLUSH THE CATHETER AND THE TUBING PER STANDARD TECHNIQUE TO ENSURE PURGING OF TRAPPED AIR BUBBLES AND TO VERIFY THAT THE IRRIGATION HOLES ARE PATENT. 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) ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH AND AT THE BEGINNING OF THE ABLATION PHASE AND THEREFORE AT HIGH FLOW, THE CATHETER DID NOT ALLOW ADEQUATE IRRIGATION (HIGH TEMPERATURE ON SMARTABLATE). ONCE THE ABLATOR WAS DISCONNECTED FROM THE STERILE EXTENSION, THE SALINE SOLUTION FROM THE SMARTABLATE TUBING (SAT) TO THE STERILE EXTENSION FLOWED NORMALLY. HOWEVER, AS SOON AS THE CATHETER WAS CONNECTED, THE FLOW WAS BLOCKED AS IF THERE WAS SOME MECHANICAL OBSTRUCTION INSIDE THAT PREVENTED THE FLOW FROM REACHING THE TIP OF THE CATHETER. CHANGING THE STERILE EXTENSION DID NOT SOLVE THE PROBLEM. INSTEAD, CHANGING THE CATHETER RESOLVED THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE ERROR ON THE PUMP WAS RELATED TO BUBBLES. SHORTLY AFTER THE START OF EACH RADIOFREQUENCY DELIVERY, THE BUBBLE ERROR APPEARED. THIS WAS LIKELY BECAUSE, AS THE PASSAGE WAS BLOCKED WITHIN THE ABLATOR, EXCESSIVE PRESSURE WAS GENERATED AT THE PUMP LEVEL. INITIALLY, THEY TRIED TO DO AN EXTERNAL WASH TO SEE IF THERE WERE BUBBLES AT THE LEVEL OF THE SAT. THEN, THEY CHANGED THE STERILE EXTENSION THAT CONNECTED THE SAT TO THE ABLATOR, AGAIN WITHOUT SUCCESS. THEY THEN REALIZED THAT THE PROBLEM WAS AT THE LEVEL OF THE ABLATOR, BECAUSE WHEN THEY PERFORMED THE WASH, THEY NOTICED THAT NO FLUID WAS COMING OUT OF THE CATHETER TIP, AS IF THERE WAS A MECHANICAL OBSTRUCTION INSIDE. REPLACING THE CATHETER RESOLVED THE ISSUE. THE HIGH TEMPERATURE AND BUBBLE ERROR ARE NOT MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538566 THERMOCOOL SMARTTOUCH CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31547913M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SMARTABLATE GENERATOR KIT-WW.| UNK_SMARTABLATE PUMP TUBING.| UNK_SMARTABLATE PUMP.