BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 25174002 · Received May 14, 2026

    Report

    Report Number
    2029046-2026-01573
    Event Type
    Injury
    Date Received
    May 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: LAKKIREDDY D, KATAPADI A, GARG J, HERINK E, KLOTZ M, GANTA J, KABRA A, KABRA R, POTHINENI NV, DARDEN D, TUMMALA R, KOERBER S, GOPINATHANNAIR R, BOMMANA S, ATKINS D, CHAUDHARY R, MBAI M, THOLAKANAHALLI V, MOHANTY S, DIBIASE L, NATALE A. NEMESIS-PFA: INVESTIGATING COLLATERAL TISSUE INJURY ASSOCIATED WITH PULSED FIELD ABLATION. JACC CLIN ELECTROPHYSIOL. 2025 AUG;11(8):1747-1756. DOI: 10.1016/J.JACEP.2025.04.017. EPUB 2025 APR 24. PMID: 40392666. D4. CATALOG: UNK_SMART TOUCH UNIDIRECTIONAL SF. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: LAKKIREDDY D, KATAPADI A, GARG J, HERINK E, KLOTZ M, GANTA J, KABRA A, KABRA R, POTHINENI NV, DARDEN D, TUMMALA R, KOERBER S, GOPINATHANNAIR R, BOMMANA S, ATKINS D, CHAUDHARY R, MBAI M, THOLAKANAHALLI V, MOHANTY S, DIBIASE L, NATALE A. NEMESIS-PFA: INVESTIGATING COLLATERAL TISSUE INJURY ASSOCIATED WITH PULSED FIELD ABLATION. JACC CLIN ELECTROPHYSIOL. 2025 AUG;11(8):1747-1756. DOI: 10.1016/J.JACEP.2025.04.017. EPUB 2025 APR 24. PMID: 40392666. BACKGROUND: EARLY EVIDENCE SHOWED REDUCED COMPLICATIONS WITH PULSED FIELD ABLATION (PFA),BUTNON-TARGET TISSUE COLLATERAL DAMAGE CREATED BY ELECTROPORATION EFFECTS IS POORLY UNDERSTOOD AND MAY SIGNIFICANTLY DIFFER BETWEEN SYSTEMS. OBJECTIVES: IN THIS STUDY, THE AUTHORS EVALUATED THE COLLATERAL EFFECTS OF PFA. METHODS: NEMESIS-PFA IS A MULTICENTER, OBSERVATIONAL REGISTRY OF PATIENTS WHO UNDERWENT AF ABLATION FROM MARCH 2024 ONWARDS WITH ANY APPROVED PFA SYSTEMS¿EITHER A CIRCULAR MULTIELECTRODE ARRAY, SPHERICAL, PENTASPLINE, OR VARIABLE LOOP CATHETER¿OR RADIO FREQUENCY ABLATION (RFA).WE ASSESSED PROCEDURAL CHARACTERISTICS, BIOMARKERS FOR MYOCARDIAL INJURY ,HEMOLYTIC ANEMIA, AND RENAL FUNCTION, AND LEFT ATRIAL FUNCTION IN SELECT PATIENTS. CONCLUSIONS: CURRENT PFA TECHNOLOGIES ARE ASSOCIATED WITH WORSE TROPONIN LEAK, HEMOLYSIS, AND RENAL DYSFUNCTION THAN RFA. AS PFA BECOMES MAINSTREAM, FUTURE STUDIES APPRAISING THESE EFFECTS AND UNDERSTANDING THE SHORT TERM AND LONG-TERM IMPLICATIONS ARE NEEDED. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PULSED FIELD ABLATION (PFA GROUP) - VARIPULSE (BIOSENSE WEBSTER), RADIOFREQUENCY ABLATION (RFA GROUP) - THERMOCOOL SMARTTOUCH SURROUND FLOW (BIOSENSE WEBSTER) OTHER BWI PRODUCTS: NONE. NON-BWI DEVICES: CIRCULAR MULTIELECTRODE ARRAY (PULSESELECT, MEDTRONIC), SPHERICAL (AFFERA SPHERE-9, MEDTRONIC), PENTASPLINE (FARAWAVE, BOSTON SCIENTIFIC). PSEUDOANEURYSM COMPLICATION WAS REPORTED IN BOTH GROUP: PFA GROUP (0.1%), RFA GROUP (0.1%). THIS ADVERSE EVENT COULD BE ASSOCIATED WITH THE USE OF SHEATH, WHICH WAS SYSTEMATICALLY USED TO IMPROVE CATHETER CONTACT AND STABILITY; HOWEVER, THE SPECIFIC DEVICE MODEL WAS NOT SPECIFIED. THE FOLLOWING ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS CANNOT BE ASSOCIATED WITH A SPECIFIC DEVICE MANUFACTURER DUE TO INSUFFICIENT INFORMATION FOR THE DEVICES USED DURING PFA WERE (MENTIONED DEVICES). QTY 21: 21 CASES OF TRANSIENT INTRAPROCEDURAL ST-SEGMENT ELEVATION. NO INTERVENTION MENTIONED: QTY 1: 0.4% CASES OF PERICARDIAL EFFUSION WITH INTERVENTION. QTY 1: 0.4% CASES OF PERICARDIAL EFFUSION WITHOUT INTERVENTION. QTY 1: 0.4% CASES OF GROIN BLEEDING. NO INTERVENTION MENTIONED. QTY 1: 0.1% CASES OF GROIN HEMATOMA NO INTERVENTION MENTIONED. QTY 1: 0.1% CASES OF HEMATURIA REQUIRING TRANSFUSION. QTY 1: 0.1% CASES OF SEVERE BRADYCARDIA. NO INTERVENTION MENTIONED. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: UNK_SMART TOUCH UNIDIRECTIONAL SF: QTY 1: 2.0% CASES OF PERICARDIAL EFFUSION WITH INTERVENTION. QTY 1: 3.1% CASES OF PERICARDIAL EFFUSION WITHOUT INTERVENTION. QTY 1: 2.0% CASES OF RESPIRATORY FAILURE. NO INTERVENTION MENTIONED. QTY 1: 2.0% CASES OF SEVERE BRADYCARDIA. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468184 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R