BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 15686739 · Received October 27, 2022

    Report

    Report Number
    2029046-2022-02668
    Event Type
    Injury
    Date Received
    October 27, 2022
    Date of Event
    May 6, 2022
    Report Date
    October 27, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITATION HAS BEEN REVIEWED: SEKI R, NAGASE T, ASANO S, FUKUNAGA H, INOUE K, SEKIGUCHI Y, TANIZAKI K, NANASATO M, UMEMURA J, NITTA J, ISOBE M. RADIOFREQUENCY CURRENT VERSUS BALLOON-BASED ABLATION FOR ATRIAL FIBRILLATION. AM J CARDIOL. 2022 SEP 1;178:52-59. DOI: 10.1016/J.AMJCARD. 2022. 05. 029 . EPUB 2022 JUL 8. PMID: 35817597. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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 CITATION HAS BEEN REVIEWED: SEKI R, NAGASE T, ASANO S, FUKUNAGA H, INOUE K, SEKIGUCHI Y, TANIZAKI K, NANASATO M, UMEMURA J, NITTA J, ISOBE M. RADIOFREQUENCY CURRENT VERSUS BALLOON-BASED ABLATION FOR ATRIAL FIBRILLATION. AM J CARDIOL. 2022 SEP 1;178:52-59. DOI: 10.1016/J.AMJCARD. 2022. 05. 029 . EPUB 2022 JUL 8. PMID: 35817597. OBJECTIVE/METHODS/STUDY DATA: AUTHORS COMPARED PROCEDURAL DATA AND EFFICACY IN A PROPENSITY SCORE-MATCHED COHORT TREATED WITH 4 ABLATION TECHNOLOGIES IN A CENTER MAINLY USING CRYOBALLOON (CB). FROM JANUARY 2019 TO APRIL 2021, ), A TOTAL OF 819 CONSECUTIVE PATIENTS WITH AF UNDERWENT PVI, USING RADIOFREQUENCY CURRENT (RFC) (65 PATIENTS), CB (693 PATIENTS), HOT BALLOON (HB) (74 PATIENTS), AND LASER BALLOON (LB) (52 PATIENTS). FIFTY PATIENTS (82% PAROXYSMAL AF) WERE SELECTED FROM EACH GROUP ACCORDING TO THE PROPENSITY SCORE. PROCEDURAL DATA AND FREEDOM FROM ATRIAL TACHYARRHYTHMIA RECURRENCE AFTER THE INDEX PROCEDURE WERE COMPARED. ALL PULMONARY VEINS WERE ISOLATED IN ALL GROUPS. PROCEDURE TIME WAS SHORTER IN CB AND HB GROUPS (RFC: 148 ± 53 VS CB: 85 ± 37 VS HB: 102 ± 31 VS LB: 140 ± 28 MINUTES, P <0.001). RFC TOUCH-UP WAS MOST COMMONLY REQUIRED FOR PVI IN THE HB GROUP AMONG BALLOON GROUPS (40%) (P <0.001). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: THERMOCOOL SMARTTOUCH SURROUND FLOW OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO 3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: SHEATH (8.5 F SHEATH, SL0, ABBOTT, ST. PAUL, MINNESOTA), DEFLECTABLE SHEATH (FLEXCATH ADVANCE, MEDTRONIC, MINNEAPOLIS, MINNESOTA), DEFLECTABLE SHEATHS (RFC, AGILIS NXT, ABBOTT; HB, TRESWALTZ, TORAY INDUSTRIES, INC, TOKYO, JAPAN) , DEFLECTABLE SHEATH (CARDIOFOCUS, MARLBOROUGH, MASSACHUSETTS), SECOND-GENERATION (ARCTIC FRONT ADVANCE, MEDTRONIC) AND FOURTH-GENERATION CBS (ARCTIC FRONT ADVANCE PRO, MEDTRONIC), SPIRAL MAPPING CATHETER (ACHIEVE, 20 MM, MEDTRONIC), SPIRAL MAPPING CATHETER (LIBERO, JAPAN LIFELINE) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 - STROKE ( IN THE HB GROUP) - TREATED WITH INTRAVENOUS EDARAVONE AND FULLY RECOVERED 6 MONTHS AFTER DISCHARGE. QTY 3 - CARDIAC TAMPONADE-( 1 EACH IN RFC, CB AND HB GROUP)- AFTER PERICARDIOCENTESIS, THE 3 PATIENTS RECOVERED WITHOUT SEQUELAE. QTY 1 - GASTRIC HYPOMOTILITY ( IN LB GROUP) - RECOVERED COMPLETELY OVER TIME BY CONSERVATIVE OBSERVATION. QTY 11 - PHRENIC NERVE INJURY ( 8 IN CB GROUP, 3 IN LB GROUP) - ALL RESOLVED. QTY 4- DECOMPENSATED HEART FAILURE ( 1 IN RFC, 2 IN HB, AND 1 IN LB GROUP) - RESOLVED IN ALL PATIENTS, WITH DIURETICS AND OXYGEN THERAPY BEFORE DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2912658 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening CARTO 3| DEFLECTABLE SHEATH (CARDIOFOCUS)| DEFLECTABLE SHEATH (FLEXCATH ADVANCE, MEDTRONIC)| DEFLECTABLE SHEATHS (HB, TRESWALTZ, TORAY)| DEFLECTABLE SHEATHS (RFC, AGILIS NXT, ABBOTT)| FOURTH-GENERATION CBS (ARCTIC FRONT ADVANCE PRO)| SECOND-GENERATION CBS (ARCTIC FRONT ADVANCE)| SHEATH (8.5 F SHEATH, SL0, ABBOTT)| SPIRAL MAPPING CATHETER (ACHIEVE, 20 MM)| SPIRAL MAPPING CATHETER (LIBERO, JAPAN LIFELINE)