BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 22391775 · Received July 2, 2025

    Report

    Report Number
    2029046-2025-02169
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 5, 2025
    Report Date
    August 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010176
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION 24-JUN-2025. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING JOHNSON & JOHNSON MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED. NO MAGNETIC, FORCE, IRRIGATION, DEFLECTION, TEMPERATURE OR ELECTRICAL ISSUES WERE FOUND DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. NO ISSUES WERE OBSERVED DURING THE ANALYSIS. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE 3500A INITIAL INCLUDED, ¿THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE THREE QDOT MICRO CATHETERS AND THE THERMOCOOL SMARTTOUCH SF CATHETER.¿ HOWEVER, AFTER FURTHER REVIEW ON 07-JUL-2025, REASSESSED THE ADVERSE EVENT ONLY REPORTABLE UNDER THE THERMOCOOL SMARTTOUCH SF CATHETER AS IT IS THE MOST SUSPECTED DEVICE. THE THERMOCOOL SMARTTOUCH SF CATHETER DELIVERED RF ENERGY DIRECTLY TO THE CARDIAC TISSUE. ALTHOUGH THE PHYSICIAN REPORTED THAT THE POSSIBLE CAUSE OF THE EFFUSION WAS THAT HE "WENT IN BLINDLY" WITH THE "ABLATOR", NO ABLATION WAS PERFORMED WITH THE QDOT MICRO CATHETERS AND IT WAS MADE CLEAR THAT THE PHYSICIAN HAD ICE IMAGING AVAILABLE. ADDITIONALLY, IT IS NOT CLEAR IF THE PHYSICIAN CONFIRMED THAT HE WAS REFERRING TO QDOT MICRO CATHETERS OR THE THERMOCOOL SMARTTOUCH SF CATHETER AS THE "ABLATOR". THE ADVERSE EVENT DID NOT OCCUR UNTIL POST PROCEDURE. THEREFORE, THE THREE QDOT MICRO CATHETERS WERE REASSESSED TO NOT REPORTABLE CONCOMITANT PRODUCTS. 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 ABLATION / WATCHMAN PROCEDURE WITH THREE QDOT MICRO CATHETERS AND A THERMOCOOL SMARTTOUCH SF CATHETER AND THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION THAT REQUIRED A PERICARDIOCENTESIS. FIRST ERROR THAT OCCURRED DURING THE PROCEDURE WAS ERROR 218 (NON COMPATIBLE GENERATOR) AND AT THE SAME TIME, THE OCTARAY CATHETER WAS UNABLE TO MAP / FAM. THE QDOT DONGLE WAS UNPLUGGED FROM THE PATIENT INTERFACE UNIT (PIU) AND THAT CLEARED THE 218 ERROR AND FAM WAS ENABLED. IT WAS NOTICED THAT THE PIU WAS DISCONNECTED FROM THE NGEN THROUGH THE CONNECTION TAB ON THE MONITOR FROM THE LAST CASE (WHICH WAS AN ATRIOVENTRICULAR (AV) NODE ABLATION WHICH WAS DONE PURPOSEFULLY AND NOT DUE TO A MALFUNCTION). NGEN CABLES WERE CONNECTED TO THE PIU, IT WAS DISCONNECTED FROM THE SYSTEM THROUGH THE CONNECTION TAB ON THE MONITOR. ONCE, IT WAS CONNECTED THE ERROR CLEARED. THE SYSTEM WAS REBOOTED MID CASE AFTER THE PIU WAS PLUGGED IN AND THE 218 ERROR RESOLVED. THEN, 3 SEPARATE QDOT MICRO CATHETERS HAD ERROR 105 (MAP SENSOR ERROR) WHEN PLUGGED IN AND INSERTED INTO THE PATIENT AND THE PHYSICIAN COULD NOT SEE THE CATHETERS ON CARTO 3. FOR TROUBLESHOOTING WITH THE FIRST QDOT MICRO, THE CABLE WAS CHANGED, AND THE CATHETER WAS CHANGED; HOWEVER, STILL HAD THE ERROR 105 DISPLAYED. THE SECOND QDOT MICRO WAS REPLACED WITH ANOTHER QDOT MICRO, BUT THIS TIME WITH A DIFFERENT LOT NUMBER. THE ERROR 105 REMAINED, SO THE CARTO 3 SYSTEM WAS REBOOTED BUT THE ERROR 105 REMAINED. THIS IS WHEN THE QDOT MICRO CATHETERS WERE CHANGED TO THE THERMOCOOL SMARTTOUCH SF CATHETER. TO NOTE: ALL QDOT MICRO CATHETERS WERE INSIDE THE BODY; HOWEVER, NO ABLATION OCCURRED WITH THE QDOT MICRO CATHETERS. THEN, THERMOCOOL SMARTTOUCH SF CATHETER WAS INSERTED INTO THE BODY AND SOME ABLATION OCCURRED; HOWEVER, THERE WAS NO ECG READING ON THE CARTO 3, BUT THERE WAS ECG ON THE RECORDING SYSTEM. THE CATHETER WAS RE-ZEROED BUT THE ECG ERROR PERSISTED. ADDITIONALLY, NO IMPEDANCE WAS SEEN ON CARTO 3; HOWEVER, IT WAS SEEN ON THE NGEN. THE PHYSICIAN ALSO COULD NOT GET THE VISITAG TO WORK ON THE CARTO 3. NO ADDITIONAL TROUBLESHOOTING OCCURRED BECAUSE PHYSICIAN DID NOT FEEL COMFORTABLE CONTINUING WITH THE PROCEDURE, SO THE ATRIAL FIBRILLATION PROCEDURE WAS CANCELLED AND THE PHYSICIAN CONTINUED WITH THE WATCHMAN PORTION OF THE CASE. AFTER THE WATCHMAN, A NEW STUDY WAS OPENED AND THE ECG WAS SEEN ON CARTO 3 (THAT WAS THE ONLY THING THAT THEY WERE ABLE TO TEST/SEE AT THIS POINT); HOWEVER, THE PHYSICIAN DID NOT WANT TO FINISH ABLATION. AT THE END OF THE CASE, THE PATIENT HAD A PERICARDIAL EFFUSION THAT WAS TREATED WITH PERICARDIOCENTESIS. THE PATIENT WAS STABLE AFTERWARDS. THE PHYSICIAN REPORTED THAT THE CAUSE OF THE EFFUSION WAS THAT HE "WENT IN BLINDLY WITH THE ABLATION CATHETER" ALTHOUGH HE DID NOT SPECIFY WHICH ABLATION CATHETER, THE QDOT MICRO CATHETERS WERE THE CATHETERS HE COULD NOT SEE ON THE CARTO. IT IS IMPORTANT TO NOTE THAT THE PHYSICIAN WAS ACROSS THE SEPTUM WITH THE VIZIGO SHEATH AND HAD INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AVAILABLE. THE ENGINEER CAME ON SIGHT AND NOTED DAMAGE TO THE PIU (BENT PINS); HOWEVER, AFTER REPLACING THE DAMAGED PIU PART, THE QDOT MICRO CATHETER ERROR REMAINED AND THEREFORE, IT WAS BELIEVED THAT THERE WERE ALSO 3 MALFUNCTIONING CATHETERS AND ONE MALFUNCTIONING CABLE. ADDITIONAL INFORMATION WAS RECEIVED. THE NGEN WAS PURPOSEFULLY DISCONNECTED FROM THE SYSTEM (UNDER CONNECTION TAB ON THE NGEN MONITOR) FOR AN AV NODE ABLATION. AFTER THE PREVIOUS AV NODE CASE WAS DONE, IT WAS FORGOTTEN TO CONNECT IT BACK TO THE SYSTEM. THE PHYSICIAN ABLATED FOR ABOUT 30 SECONDS AND SINCE HE COULD NOT GET A VISITAG, HE CANCELLED THE ATRIAL FIBRILLATION PORTION OF THE CASE AND CONTINUED WITH THE WATCHMAN. MINIMAL ABLATION WAS DONE WITH THE THERMOCOOL SMARTTOUCH SF CATHETER. ADVERSE EVENT WAS NOT DUE TO CARTO 3. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE THREE QDOT MICRO CATHETERS AND THE THERMOCOOL SMARTTOUCH SF CATHETER. THE IMPEDANCE ISSUE, MAGNETIC SENSOR ERROR AND VISUALIZATION ISSUE, WERE ASSESSED AS NON MDR REPORTABLE. THE DEVICE CANNOT BE USED DURING THESE ISSUES AND WILL NEED TO BE REPLACED. THE NO ECG READING ON CARTO 3 ISSUE AND ERROR 218 ARE ALSO NON MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE FOR THESE NON MDR REPORTABLE EVENTS IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. LASTLY, THE VISITAG ISSUE WAS ALSO ASSESSED AS NON MDR REPORTABLE. VISITAG PROVIDES SUPPLEMENTAL INFORMATION TO AID IN ABLATION PROCEDURES. IF VISITAG POINTS ARE LOST, INACCURATE, OR UNABLE TO BE OBTAINED, THEN THIS IS HIGHLY DETECTABLE. THE ACQUISITION OF VISITAG POINTS IS NOT NECESSARY TO PERFORM ABLATION PROCEDURES. POINTS CAN BE TAKEN MANUALLY, AND ECG RHYTHM IS THE ULTIMATE GUIDING FEATURE OF ABLATION PROCEDURES. AN ISSUE WITH VISITAG DOES NOT AFFECT PATIENT RISK. THE NO ECG READING ISSUE AND ERROR 218 ARE ALSO NON MDR REPORTABLE. THE RISK TO THE PATIENT WAS LOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793505 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31549238L 10846835010176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R 6FR CS, F,10 POLE,12 PIN, AUTOID.| 8.5F SHEATH WITH CURVE VIZ MDC.| CARTO 3 SYSTEM.| EXTENSION CABLE.| NGEN RF GENERATOR, US.| OCTA, STD,48P,2-2-2-2-2, F-CURVE.| QDOT MICRO, BI, TC, F-J.| QDOT MICRO, BI, TC, F-J.| QDOT MICRO, BI, TC, F-J.| SMARTABLATE IRR TUBE SET.| UNK CATHETER CABLE.| UNK ECO CABLE.| UNK NGEN CABLE.| UNK RECORDING SYSTEM.