BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 15828136 · Received November 18, 2022

    Report

    Report Number
    3005334138-2022-00628
    Event Type
    Injury
    Date Received
    November 18, 2022
    Report Date
    December 11, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE MINOR COMPLICATION IN A PATIENT TREATED WITH RMN WHO HAD TEMPORARY AV BLOCK, THAT RESOLVED COMPLETELY AFTER THE PROCEDURE. TACTICATH SE DEVICES ARE NOT USED DURING RMN PROCEDURES, ONLY DURING MAN PROCEDURES. THEREFORE THE TACTICATH SE WOULD NOT BE ASSOCIATED WITH THE AV BLOCK THAT OCCURRED, MAKING THIS EVENT NOT REPORTABLE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE PEDIATRIC CARDIOLOGYY (2022) 43:1695¿1703. TITLED ¿THE FIRST EVALUATION OF REMOTE MAGNETIC NAVIGATION-GUIDED PEDIATRIC VENTRICULAR ARRHYTHMIA ABLATION", ANNA M. E. NOTEN. RECEIVED: 10 JANUARY 2022 / ACCEPTED: 28 MARCH 2022 / PUBLISHED ONLINE: 29 APRIL 2022. THIS SINGLE-CENTER, RETROSPECTIVE STUDY, INVESTIGATED ALL CONSECUTIVE CA PROCEDURES USING RMN OR MANUAL-GUIDED RF TECHNIQUES IN CHILDREN (AGED<18 YEARS) AS TREATMENT OF DOCUMENTED VA (INCLUDING PVC OR VT) BETWEEN THE 1ST OF JANUARY 2008 UNTIL 31TH OF DECEMBER 2020. WE EXCLUDED PATIENTS IN WHOM CROSS-OVER BETWEEN CA TECHNIQUES OCCURRED. OUTCOMES WERE COMPARED BETWEEN TWO GROUPS, BASED ON THE ABLATION TECHNIQUE USED: CONVENTIONAL MANUAL-GUIDED RF ABLATION (MAN) OR RMN-GUIDED RF ABLATION (RMN). ALL PATIENTS SCHEDULED FOR VA ABLATION WERE DISTRIBUTED FROM THE WAITING LIST BASED ON AVAILABILITY TO THE RMN-EQUIPPED OR THE CONVENTIONAL EP LABORATORY. ACCORDINGLY, ABLATION WAS PERFORMED EITHER USING RMN OR USING CONVENTIONAL MAN. THE PROCEDURES WERE PERFORMED OVER THE ENTIRE STUDY DURATION BY THE SAME SENIOR ELECTROPHYSIOLOGIST GROUP WITH THE ASSISTANCE OF FELLOWS, TRAINED FOR MANUAL CATHETER NAVIGATION AS WELL AS FOR RMN. THE ATTENDING PHYSICIANS PERFORMED RMN AND MAN PROCEDURES IN EQUAL DISTRIBUTION. THE PRIMARY ENDPOINT FOR PVC ABLATION WAS>90% REDUCTION IN PVC BURDEN IN COMPARISON TO BASELINE DURING LONG-TERM FOLLOW-UP AS MEASURED BY HOLTER CONTINUOUS RHYTHM OBSERVATION. THE PRIMARY ENDPOINT FOR VT ABLATION WAS ABSENCE OF RECURRENCE OF SUSTAINED VT DURING LONG-TERM FOLLOW-UP. WE ALSO ANALYZED THE FOLLOWING SECONDARY ENDPOINTS: PROCEDURAL PARAMETERS (INCLUDING FUOROSCOPY DOSAGES), ACUTE PROCEDURE SUCCESS, REDO PROCEDURE RATES, AND COMPLICATION RATES. THE STUDY PROTOCOL CONFORMS TO THE ETHICAL GUIDELINES OF THE 1975 DECLARATION OF HELSINKI. THE LOCAL MEDICAL ETHICS COMMITTEE DETERMINED THIS STUDY WAS NOT SUBJECT TO THE DUTCH MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS ACT (WMO). THE NEED FOR INDIVIDUAL CONSENT WAS WAIVED BY THE LOCAL MEDICAL ETHICAL COMMITTEE. TEMPORARY AV BLOCK THAT RESOLVED COMPLETELY AFTER THE PROCEDURE.

    Description of Event or Problem · 0

    ONE MINOR COMPLICATION IN A PATIENT TREATED WITH RMN WHO HAD TEMPORARY AV BLOCK, THAT RESOLVED COMPLETELY AFTER THE PROCEDURE. TACTICATH SE DEVICES ARE NOT USED DURING RMN PROCEDURES, ONLY DURING MAN PROCEDURES. THEREFORE THE TACTICATH SE WOULD NOT BE ASSOCIATED WITH THE AV BLOCK THAT OCCURRED, MAKING THIS EVENT NOT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322874 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown