BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 22292583 · Received June 19, 2025

    Report

    Report Number
    2029046-2025-02006
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    April 1, 2025
    Report Date
    June 19, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 ARTICLE HAS BEEN REVIEWED: SIMONE NDS, LUIS RLDS, FABIO M, ANDRÉ RZ, FABIO MNB, BENHUR DH. LEFT ATRIAL INTRAMURAL HEMATOMA DURING RADIOFREQUENCY CATHETER ABLATION FOR ATRIAL FIBRILLATION: THE IMPORTANT ROLE OF INTRACARDIAC ECHOCARDIOGRAPHY. (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY-NC-ND/4.0/). HTTPS://DOI.ORG/10.1016/J.HRCR.2024.12.017. 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).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: SIMONE NDS, LUIS RLDS, FABIO M, ANDRÉ RZ, FABIO MNB, BENHUR DH. LEFT ATRIAL INTRAMURAL HEMATOMA DURING RADIOFREQUENCY CATHETER ABLATION FOR ATRIAL FIBRILLATION: THE IMPORTANT ROLE OF INTRACARDIAC ECHOCARDIOGRAPHY. (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY-NC-ND/4.0/). HTTPS://DOI.ORG/10.1016/J.HRCR.2024.12.017. OBJECTIVE: TO REPORT A RARE CASE OF LEFT ATRIAL INTRAMURAL HEMATOMA (IMH) DETECTED BY ICE DURING AN ABLATION OF AF. METHODS: A 70-YEAR-OLD MAN WITH A HISTORY OF LONG-STANDING, PERSISTENT AF AND TACHYCARDIOMYOPATHY (LEFT VENTRICULAR EJECTION FRACTION OF 28%) UNDERWENT SUCCESSFUL RFCA IN 2018 WITH COMPLETE RECOVERY OF LEFT VENTRICLE FUNCTION IN THE SUBSEQUENT MONTHS. THE PROCEDURE WAS PERFORMED USING AN ELECTROANATOMIC CARTO3 MAPPING SYSTEM AND CARTOSOUND MODULE (BIOSENSE WEBSTER, DIAMOND BAR, CA) UNDER UNINTERRUPTED ANTICOAGULATION WITH WARFARIN (INTERNATIONAL NORMALIZED RATIO OF 2.6 ON THE DAY OF THE PROCEDURE). ABLATION WAS PERFORMED IN A POWER-CONTROLLED MODE AT 40 W WITH A TEMPERATURE CUTOFF OF 43C WITH A THERMOCOOL SMARTTOUCH SFTM IRRIGATED, FORCE-SENSING ABLATION CATHETER (BIOSENSE WEBSTER) USING A FLOW OF 15 ML/MIN AND CONTACT BETWEEN 8 G AND 25 G AND VISITAG SURPOINT MODULE (BIOSENSE WEBSTER) TARGET OF 400¿500. CONCLUSIONS: OUR CASE DEMONSTRATES A LEFT ATRIAL IMH AFTER A STEAM POP IN PROXIMITY TO CALCIFICATION OF THE MITRAL ANNULUS AND LA PW, IN WHICH THE LESION FORMATION AND SUBSEQUENT LEFT ATRIAL IMH WERE PROMPTLY DIAGNOSED, HIGHLIGHTING THE IMPORTANCE OF ICE DURING AF ABLATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CARTO3 MAPPING SYSTEM AND CARTOSOUND MODULE (BIOSENSE WEBSTER, DIAMOND BAR, CA), THERMOCOOL SMARTTOUCH SFTM IRRIGATED, FORCE-SENSING ABLATION CATHETER (BIOSENSE WEBSTER). OTHER BWI PRODUCTS: VISITAG SURPOINT MODULE (BIOSENSE WEBSTER). NON-BWI DEVICES: NONE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 1: ICE SHOWED AN IMAGE FORMATION, HETEROGENEOUS, FILLED WITH LAYERS, SUGGESTING A DISSECTION WITHIN THE LA PW, EXTENDING BETWEEN THE INFERIOR PVS. COLOR DOPPLER DETECTED A LOW-VELOCITY BLOOD FLOW INSIDE THE IMAGE FORMATION, AND A 2.4-MM ENTERING ORIFICE WAS VISUALIZED. AS AN INTRAMURAL HEMATOMA (IMH) WAS SUSPECTED, HEPARINIZATION WAS IMMEDIATELY REVERTED AFTER THE LINE COMPLETION, AND ELECTROANATOMIC CARTO3 LA REMAPPING SHOWED COMPLETED PW ISOLATION (FIGURE 6A AND 6B). ADDITIONAL INFORMATION INCLUDED: AS AN IMH WAS SUSPECTED, HEPARINIZATION WAS IMMEDIATELY REVERTED AFTER THE LINE COMPLETION, AND ELECTROANATOMIC CARTO3 LA REMAPPING SHOWED COMPLETED PW ISOLATION (FIGURE 6A AND 6B). AFTER HEPARIN REVERSION, INCREASED ECHOGENICITY AND A REDUCTION OF LOW BLOOD FLOW INSIDE THE IMH WERE NOTICED (SUPPLEMENTAL VIDEO 4). NO PERICARDIAL EFFUSION WAS VISUALIZED AT THE END OF THE PROCEDURE OR VIA TRANSTHORACIC ECHOCARDIOGRAPHY 6 HOURS LATER. THE PATIENT REMAINED HEMODYNAMICALLY STABLE AND COMPUTED TOMOGRAPHY SCANS WERE PERFORMED ON THE FIRST DAY AFTER THE PROCEDURE, CONFIRMING THE DIAGNOSIS OF IMH. NO BLOOD FLOW WAS NOTED IN THE LATE CONTRASTENHANCED COMPUTED TOMOGRAPHY IMAGES (FIGURE 7A¿7D). THE PATIENT WAS DISCHARGED, AND COMPUTED TOMOGRAPHY SCANS PERFORMED 3 MONTHS LATER SHOWED TOTAL REGRESSION OF THE IMH (FIGURE 8A¿8D).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1639312 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R| L UNK_CARTO 3