BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER

    MDR report key: 9812130 · Received March 10, 2020

    Report

    Report Number
    2030404-2020-00017
    Event Type
    Death
    Date Received
    March 10, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: FLEXABILITY CATHETER, LIVEWIRE CATHETER, EVENT DATE UNKNOWN. 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.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2020-00100, 2182269-2020-00028. THE FOLLOWING WAS PUBLISHED IN THE INTERNATIONAL JOURNAL OF CARDIOLOGY IN AN ARTICLE TITLED ¿ELONGATION OF THE HIGH RIGHT ATRIUM TO CORONARY SINUS CONDUCTION TIME PREDICTS THE RECURRENCE OF ATRIAL FIBRILLATION AFTER RADIOFREQUENCY CATHETER ABLATION¿ BY KANEMARU Y, ARIMA Y, KAIKITA K, ET AL., 18 NOVEMBER 2019. ¿THE IMPACT OF INTRA-ATRIAL CONDUCTION DELAY ON THE RECURRENCE OF ATRIAL TACHYARRHYTHMIA AFTER RADIO FREQUENCY CATHETER ABLATION (RFCA) HAS NOT BEEN FULLY ELUCIDATED. IN THIS STUDY, 155 AF PATIENTS WHO WERE IN SINUS RHYTHM AT THE START OF RFCA WERE ANALYZED AT THE KUMAMOTO UNIVERSITY HOSPITAL FROM JANUARY 2011 TO MARCH 2017. THE CONDUCTION TIME FROM THE ONSET OF THE EARLIEST ATRIAL ELECTROGRAM AT THE HIGH RIGHT ATRIUM (HRA) TO THE END OF THE LATEST ELECTROGRAM AT THE CORONARY SINUS (CS) DURING SINUS RHYTHM WAS DEFINED AS HRA-CS CONDUCTION TIME. PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED FOLLOWED BY LINEAR ROOF LESION AND COMPLEX FRACTIONATED ATRIAL ELECTROGRAM (CFAE) ABLATION UNTIL AF TERMINATION. OF THE 155 PATIENTS, ONE DIED DUE TO AN AORTIC DISSECTION. THE CONCLUSION WAS THAT THE HRA-CS CONDUCTION TIME WAS THE PRIMARY INFLUENCING FACTOR THAT PREDICTED THE RECURRENCE OF ATRIAL TACHYARRHYTHMIA AFTER CATHETER ABLATION. (HTTPS://DOI.ORG/10.1016/J.IJCARD.2019.10.044)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274089 THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER IRRIGATED ABLATION CATHETER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death