BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 22916551 · Received August 28, 2025

    Report

    Report Number
    2029046-2025-02907
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    July 22, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DITAC G, VERHAEGHE L, PAMBRUN T, BENALI K, JOHNER N, KNEIZEH K, PLANT A, FITZGERALD JL, VLACHOS K, SACRISTAN B, CHARTON J, ARNAUD M, BOUYER B, TIXIER R, DERVAL N, HOCINI M, HAÏSSAGUERRE M, JAÏS P, SACHER F, DUCHATEAU J. TRANSATRIAL PERICARDIAL INSUFFLATION OF CARBON DIOXIDE TO FACILITATE EPICARDIAL MAPPING AND ABLATION OF ATRIAL AND VENTRICULAR ARRHYTHMIAS. HEART RHYTHM. 2025 JUL;22(7):1718-1727. DOI: 10.1016/J.HRTHM.2025.03.1967. EPUB 2025 MAR 20. PMID: 40120922. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 #: (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON (B)(6), NOTED A CORRECTION TO THE 3500A INITIAL AS H6. COMPONENT CODE WAS PROCESSED IN ERROR AS "APPROPRIATE TERM / CODE NOT AVAILABLE (G07002)" AND SHOULD HAVE BEEN PROCESSED AS "INSUFFICIENT INFORMATION (G07003)". THEREFORE, CORRECTED. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DITAC G, VERHAEGHE L, PAMBRUN T, BENALI K, JOHNER N, KNEIZEH K, PLANT A, FITZGERALD JL, VLACHOS K, SACRISTAN B, CHARTON J, ARNAUD M, BOUYER B, TIXIER R, DERVAL N, HOCINI M, HAÏSSAGUERRE M, JAÏS P, SACHER F, DUCHATEAU J. TRANSATRIAL PERICARDIAL INSUFFLATION OF CARBON DIOXIDE TO FACILITATE EPICARDIAL MAPPING AND ABLATION OF ATRIAL AND VENTRICULAR ARRHYTHMIAS. HEART RHYTHM. 2025 JUL;22(7):1718-1727. DOI: 10.1016/J.HRTHM.2025.03.1967. EPUB 2025 MAR 20. PMID: 40120922. BACKGROUND: EPICARDIAL ACCESS (EA) IS AN ESSENTIAL TOOL FOR ABLATION OF CERTAIN ARRHYTHMIAS, BUT CONVENTIONAL TECHNIQUES CARRY INHERENT RISKS. CARBON DIOXIDE (CO2) INSUFFLATION IN THE PERICARDIUM THROUGH THE CORONARY SINUS AIMS TO FACILITATE EA BUT IS TIME-CONSUMING AND NOT WIDELY USED. TRANSATRIAL PERICARDIAL INSUFFLATION OF CO2 (TAPI-CO2) OFFERS A SIMPLIFIED ALTERNATIVE, UNDEREXPLORED IN ELECTROPHYSIOLOGY PROCEDURES. OBJECTIVE: THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF TAPI-CO2 FOR EA IN ELECTROPHYSIOLOGY PROCEDURES. METHODS: THIS RETROSPECTIVE STUDY INCLUDED ALL PATIENTS UNDERGOING EA WITH TAPI-CO2 AT A TERTIARY CARE CENTER BETWEENDECEMBER 2020 AND NOVEMBER 2024. THE PROCEDURE INVOLVED INTENTIONAL RIGHT ATRIAL APPENDAGE PERFORATION FOR CO2 INSUFFLATION, FOLLOWED BY SUBXIPHOID PUNCTURE FOR EA. SUCCESS RATES, PROCEDURAL CHARACTERISTICS, AND COMPLICATIONS WERE ASSESSED. CONCLUSIONS: TAPI-CO2 IS A FEASIBLE, EFFICIENT, AND RELATIVELY SAFE TECHNIQUE FOR FACILITATING EA. IT PROVIDES A SIMPLIFIED ALTERNATIVE TO CO2 INSUFFLATION THROUGH THE CORONARY SINUS. FURTHER STUDIES ARE NEEDED TO CONFIRM THESE RESULTS AND TO IDENTIFY THE POPULATIONS OF PATIENTS THAT WOULD BENEFIT MOST FROM THIS TECHNIQUE. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL STSF; BIOSENSE WEBSTER. OTHER BWI PRODUCTS: CARTO 3 SYSTEM (BIOSENSE WEBSTER, IRVINE, CA) AND A MULTIPOLAR CATHETER (PENTARAY OR OCTARAY NAV; BIOSENSE WEBSTER). NON-BWI DEVICES: AN AGILIS NXT STEERABLE INTRODUCER (ABBOTT CARDIOVASCULAR, PLYMOUTH, MN; SIZE 8.5F), A SMALL (1.2¿1.5 MM IN DIAMETER) OVER-THE-WIRE BALLOON (MINI TREK; ABBOTT), AGILIS EPI INTRODUCER (ABBOTT) TAPI-CO2 FOR PERCUTANEOUS EPICARDIAL ACESS. PATIENT 8 HAD A PERICARDIAL EFFUSION DURING THE PROCEDURE, THEN A RECURRENCE 7 DAYS AFTER. ANTICOAGULATION WAS TEMPORARILY DISCONTINUED, AND THE PATIENT SUBSEQUENTLY SUFFERED AN ISCHEMIC STROKE 5 DAYS LATER AND REQUIRED EMERGENT THROMBECTOMY. THIS PATIENT HAD LAMINOPATHY WITH SEVERELY DECREASED LEFT VENTRICULAR EJECTION FRACTION. THIS PERICARDIAL EFFUSION WAS DEEMED VERY LIKELY TO BE RELATED TO EA. THIS PATIENT WILL NOT BE CAPTURE SINCE IT IS OBVIOUS THAT THIS IS RELATED TO EPICARDIAL ACCESS WITH TAPI-CO2. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: 1 PATIENT 11, MALE, 47-YEAR-OLD EXPERIENCED TAMPONADE DURING ENDOCARDIAL RV ABLATION FOLLOWING A STEAM POP IN THE TRICUSPID ANTERIOR PAPILLARY MUSCLE. EMERGENT DRAINAGE WAS PERFORMED, WITH A FAVORABLE OUTCOME. THIS COMPLICATION WAS DETERMINED TO BE UNRELATED TO EA BECAUSE OF ITS DIRECT ASSOCIATION WITH THE STEAM POP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087282 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention| L AGILIS EPI INTRODUCER.| AGILIS NXT STEERABLE INTRODUCER.| MINI TREK, ABBOTT SMALL OVER THE WIRE BALLOON.| MULTIPOLAR CATHETER BWI.| UNK_CARTO 3.