BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 25153444 · Received May 12, 2026

    Report

    Report Number
    2029046-2026-01551
    Event Type
    Injury
    Date Received
    May 12, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: OZA SR, HINCAPIE D, GUPTA M, VARLEY AL, THORNE C, SILVERSTEIN JR, GABR M, THOSANI AJ, MIRANDA-ARBOLEDA AF, OSORIO J, VELASCO A, JAZAYERI MA, SACKETT MC, COSTEA A, MORETTA A, KUK R, SILVA JM, D'SOUZA B, BELDEN W, METZL MD, QUIN M, MORRIS KE, ROMERO JE, STEIGER NA, SAUER W, ZEI PC. ISOPROTERENOL FOR UNMASKING DORMANT CONDUCTION AND NON-PULMONARY VEIN TRIGGERS DURING ATRIAL FIBRILLATION ABLATION: PROSPECTIVE MULTICENTER STUDY. J CARDIOVASC ELECTROPHYSIOL. 2025 SEP;36(9):2304-2317. DOI: 10.1111/JCE.70007. EPUB 2025 JUL 14. PMID: 40654209. 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 AND THE FOLLOWING CITATION WAS REVIEWED: OZA SR, HINCAPIE D, GUPTA M, VARLEY AL, THORNE C, SILVERSTEIN JR, GABR M, THOSANI AJ, MIRANDA-ARBOLEDA AF, OSORIO J, VELASCO A, JAZAYERI MA, SACKETT MC, COSTEA A, MORETTA A, KUK R, SILVA JM, D'SOUZA B, BELDEN W, METZL MD, QUIN M, MORRIS KE, ROMERO JE, STEIGER NA, SAUER W, ZEI PC. ISOPROTERENOL FOR UNMASKING DORMANT CONDUCTION AND NON-PULMONARY VEIN TRIGGERS DURING ATRIAL FIBRILLATION ABLATION: PROSPECTIVE MULTICENTER STUDY. J CARDIOVASC ELECTROPHYSIOL. 2025 SEP;36(9):2304-2317. DOI: 10.1111/JCE.70007. EPUB 2025 JUL 14. PMID: 40654209. BACKGROUND: PULMONARY VEIN (PV) RECONNECTION AND THE ONSET OF NON-PV TRIGGERS ARE FREQUENTLY THE CAUSE OF ATRIAL FIBRILLATION (AF) RECURRENCE AFTER RADIOFREQUENCY CATHETER ABLATION (RFCA). THE EFFECTIVENESS OF USING ISOPROTERENOL FOR UNMASKING DORMANT CONDUCTION AND NON-PV-TRIGGERS DURING AF RFCA AND ITS EFFECT ON IMPROVING PROCEDURAL AND CLINICAL OUTCOMES IS STILL CONTROVERSIAL. OBJECTIVE: TO EVALUATE THE EFFECTIVENESS OF ISOPROTERENOL FOR UNMASKING DORMANT CONDUCTION AND NON-PV TRIGGERS DURING RFCA FOR PAROXYSMAL AF (PAF) AND ITS EFFECTS ON PROCEDURAL AND LONG-TERM CLINICAL OUTCOMES. METHODS: IN THIS PROSPECTIVE MULTICENTER COHORT FROM THE REAL-AF REGISTRY, PATIENTS WHO UNDERWENT RFCA FOR PAF WITH AND WITHOUT ISOPROTERENOL ADMINISTRATION FROM JANUARY 2018 TO MAY 2023 WERE INCLUDED. A TOTAL OF 1102 PATIENTS WERE INCLUDED (ISOPROTERENOL=325 VS. CONTROL=777) (MEAN AGE 66.73±10.19 YEARS; 53.05% MALE). THE PRIMARY EFFICACY OUTCOME WAS FREEDOM FROM ALL-ATRIAL ARRHYTHMIA AT 12-MONTH FOLLOW-UP. SECONDARY OUTCOMES INCLUDED PROCEDURAL AND LONG-TERM CLINICAL OUTCOMES, AND PROCEDURE-RELATED COMPLICATIONS. CONCLUSION: IN PATIENTS UNDERGOING RFCA FOR PAF, THE USE OF ISOPROTERENOL WAS ASSOCIATED WITH INCREASED PROCEDURAL TIMES AND MORE EXTENSIVE ABLATION, WITHOUT IMPROVED CLINICAL OUTCOMES AT 12-MONTH FOLLOW-UP. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICES ARE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SURROUNDFLOW CATHETER (STSF; BIOSENSE WEBSTER INC., CA, USA) OTHER BWI DEVICE(S): MULTIPOLAR MAPPING CATHETER (PENTARAY OR OCTARAY, BIOSENSE WEBSTER INC., CA, USA), CATHETER STABILITY SOFTWARE (VISITAG SURPOINT MODULE, BIOSENSE WEBSTER INC.) VASCULAR ACCESS COMPLICATION WAS REPORTED IN BOTH GROUP: (N=3) IN ISOPROTERENOL GROUP AND (N=2) IN CONTROL GROUP. 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. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR UNK_SMART TOUCH UNIDIRECTIONAL SF DEVICES: QTY 24: 24 CASES OF LONG-TERM COMPLICATIONS, (N=8) ISOPROTERENOL GROUP AND (N=16) CONTROL GROUP. INTERVENTION WAS NOT DISCUSSED. QTY 11: 11 CASES OF ACUTE COMPLICATIONS, (N=3) ISOPROTERENOL GROUP AND (N=8) CONTROL GROUP. INTERVENTION WAS NOT DISCUSSED. QTY 2: 2 STROKES, (N=1) ISOPROTERENOL GROUP AND (N=1) CONTROL GROUP. INTERVENTION WAS NOT DISCUSSED. QTY 5: 5 PERICARDITIS, (N=1) ISOPROTERENOL GROUP AND (N=4) CONTROL GROUP. INTERVENTION WAS NOT DISCUSSED. QTY 1: 1 PHRENIC NERVE INJURY IN ISOPROTERENOL GROUP. INTERVENTION WAS NOT DISCUSSED. QTY 1: 1 ATRIOESOPHAGEAL FISTULA IN ISOPROTERENOL GROUP. INTERVENTION WAS NOT DISCUSSED. QTY 1: 1 PULMONARY VEIN STENOSIS IN CONTROL GROUP. INTERVENTION WAS NOT DISCUSSED. QTY 1: 1 DEATH IN CONTROL GROUP. INTERVENTION WAS NOT DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596170 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening