BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 16824475 · Received April 27, 2023

    Report

    Report Number
    3005334138-2023-00165
    Event Type
    Injury
    Date Received
    April 27, 2023
    Report Date
    May 22, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF CARDIOLOGY 81.5: 464-468. JAPANESE COLLEGE OF CARDIOLOGY DOI: HTTP://DX.DOI.ORG/10.1016/J.JJCC.2023.02.005 "ADDING INTERACTIVE FACE-TO-FACE LECTURES TO PASSIVE LECTURES EFFECTIVELY REDUCES RADIATION EXPOSURE DURING ATRIAL FIBRILLATION ABLATION"; MIYAZAKI, YUICHIRO. RADIATION EXPOSURE REMAINS A MAJOR CONCERN FOR ELECTROPHYSIOLOGISTS AND PATIENTS. THIS STUDY AIMED TO INVESTIGATE THE EFFECT OF ALTERING AWARENESS OF RADIATION EXPOSURE DURING ATRIAL FIBRILLATION ABLATION USING INTERACTIVE FACE-TO-FACE (FTF) LECTURES COMPARED TO PASSIVE LECTURES. METHODS: PATIENTS WHO UNDERWENT THEIR FIRST CATHETER ABLATION WITH RADIOFREQUENCY ENERGY FOR ATRIAL FIBRILLATION BETWEEN JANUARY 2014 AND DECEMBER 2020 WERE INCLUDED IN THIS STUDY. ALL OPERATORS ATTENDED AN E-LEARNING LECTURE ON RADIATION EXPOSURE BEFORE CATHETER ABLATION. THE ADDITION OF FTF LECTURES TO THIS LECTURE WAS INTRODUCED IN 2018. THE EFFECT ON RADIATION EXPOSURE WAS COMPARED BETWEEN THE PRE-FTF AND FTF PERIODS BY COMPARING FLUOROSCOPY TIME AND RADIATION DOSE. A TOTAL OF 896 PATIENTS WERE INCLUDED IN THIS STUDY. FOR PRE-FTF, ONLY PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED IN 112 PATIENTS AND PVI WITH ADDITIONAL ABLATION IN 233 PATIENTS. FOR FTF LECTURES, PVI-ONLY WAS PERFORMED IN 302 PATIENTS AND PVI WITH ADDITIONAL ABLATION IN 249 PATIENTS. FLUOROSCOPY TIME, CUMULATIVE AIR KERMA, AND CUMULATIVE AIR KERMA PER TIME SIGNIFICANTLY REDUCED AFTER FTF INTRODUCTION IN BOTH PVI-ONLY GROUP [PRE-FTF AND FTF; 37 ± 15 MIN AND 16 ± 10 MIN, 477 ± 582 MGY AND 108 ± 156 MGY, 11 ± 12 MGY/MIN, AND 5 ± 6 MGY/MIN, RESPECTIVELY] AND PVI WITH ADDITIONAL ABLATION GROUP [PRE-FTF AND FTF; 48 ± 17 MIN AND 15 ± 13 MIN, 613 ± 483 MGY AND 68 ± 96 MGY, 12 ± 10 MGY/MIN, AND 4 ± 4 MGY/MIN, RESPECTIVELY]. THERE WERE NO SIGNIFICANT DIFFERENCES IN INTRAOPERATIVE COMPLICATIONS BETWEEN THE TWO PERIODS. CONCLUSIONS: FTF LECTURES CAN REDUCE RADIATION EXPOSURE. CARDIAC TAMPONADE OCCURRED IN SIX PATIENTS REQUIRING PERICARDIOCENTESIS. NO OTHER INTRAOPERATIVE COMPLICATIONS REQUIRING INVASIVE TREATMENT WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559506 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 Required Intervention