BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 14694736 · Received June 15, 2022

    Report

    Report Number
    2029046-2022-01315
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    April 21, 2021
    Report Date
    June 15, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: YU M, HOU L, YU H, GE J, LI P, GUO Z, HUANG X, ZHAO X, CAO J, HUANG S. ELECTROCARDIOGRAPHIC AND ELECTROPHYSIOLOGICAL CHARACTERISTICS OF IDIOPATHIC VENTRICULAR ARRHYTHMIAS ORIGINATING FROM THE VICINITY OF TRICUSPID ANNULUS. SCI REP. 2021 APR 21;11(1):8633. DOI: 10.1038/S41598-021-88036-7. PMID: 33883631; PMCID: PMC8060328. 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 THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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 CITE HAS BEEN REVIEWED: YU M, HOU L, YU H, GE J, LI P, GUO Z, HUANG X, ZHAO X, CAO J, HUANG S. ELECTROCARDIOGRAPHIC AND ELECTROPHYSIOLOGICAL CHARACTERISTICS OF IDIOPATHIC VENTRICULAR ARRHYTHMIAS ORIGINATING FROM THE VICINITY OF TRICUSPID ANNULUS. SCI REP. 2021 APR 21;11(1):8633. DOI: 10.1038/S41598-021-88036-7. PMID: 33883631; PMCID: PMC8060328. OBJECTIVE/METHODS/STUDY DATA: ELECTROCARDIOGRAPHIC AND ELECTROPHYSIOLOGICAL CHARACTERISTICS OF VAS ORIGINATING FROM THE VICINITY OF THE TA ARE NOT FULLY UNDERSTOOD. HENCE, 104 PATIENTS (MEAN AGE 52.6 ± 17.9 YEARS; 62 MALE) WITH VAS ORIGINATING FROM THE VICINITY OF THE TA WERE ENROLLED. AFTER ELECTROPHYSIOLOGICAL EVALUATION AND ABLATION, DATA WERE COMPARED AMONG THOSE PATIENTS. THE ECGS AND THE CORRECTION OF THE ECGS BASED ON THE LONG AXIS OF THE HEART CALCULATED FROM THE CHEST X-RAY WERE ALSO ANALYZED. VAS ORIGINATING FROM THE VICINITY OF TA HAD DISTINCTIVE ECG CHARACTERISTICS THAT WERE USEFUL FOR IDENTIFYING THE PRECISE ORIGIN. OUR LOCALIZATION ALGORITHM ADJUSTED BY THE ANGLE BETWEEN THE CARDIAC LONG AXIS AND THE HORIZON WAS FOUND TO BE ACCURATE IN PREDICTING THE EXACT ABLATION SITE IN 92.3% (N= 96) CASES. LOGISTIC REGRESSION ANALYSIS SHOWED FRACTIONATED ELECTROGRAMS, THE MAGNITUDES OF THE LOCAL ATRIAL ELECTROGRAMS AND A/V RATIO WERE CRITICAL FACTORS FOR SUCCESSFUL ABLATION. AMONG THE 104 PATIENTS WITH VAS, COMPLETE ELIMINATION COULD BE ACHIEVED BY RFCA IN 96 PATIENTS (SUCCESS RATE 92.3%) DURING A FOLLOW-UP PERIOD OF 35.2 ± 19.6 MONTHS. THIS STUDY SUGGESTS THAT THE ABLATION SITE COULD BE LOCALIZED BY ECG ANALYSIS ADJUSTED BY THE ANGLE BETWEEN THE CARDIAC LONG AXIS AND THE HORIZON. FRACTIONATED ELECTROGRAMS, THE MAGNITUDES OF THE LOCAL ATRIAL ELECTROGRAMS AND A/V RATIO WERE DEMONSTRATED TO BE CRITICAL FACTORS FOR SUCCESSFUL ABLATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: AN 8-F ABLATION CATHETER WITH A 4-MM DISTAL ELECTRODE (BIOSENSE WEBSTER, DIAMOND BAR, CALIFORNIA, USA). OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-BIOSENSE WEBSTER CONCOMITANT DEVICES THAT WERE ALSO USED IN THIS STUDY: NAV-X, ST.JUDE MEDICAL, ST. PAUL, MINNESOTA . A SWARTZ INTRODUCER SHEATH . ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ACUTE CARDIAC TAMPONADE OCCURRED IN ONE PATIENT AND PERICARDIOCENTESIS WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2813662 THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R A SWARTZ INTRODUCER SHEATH| NAV-X, ST.JUDE MEDICAL, ST. PAUL, MINNESOTA