BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS INTRODUCER, UNKNOWN

    MDR report key: 10573281 · Received September 23, 2020

    Report

    Report Number
    3008452825-2020-00496
    Event Type
    Injury
    Date Received
    September 23, 2020
    Report Date
    October 28, 2020
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN CIRCULATION. ARRHYTHMIA AND ELECTROPHYSIOLOGY, IN AN ARTICLE TITLED ¿PULMONARY VEIN ISOLATION WITH SINGLE PULSE IRREVERSIBLE ELECTROPORATION: A FIRST IN HUMAN STUDY IN 10 PATIENTS WITH ATRIAL FIBRILLATION" BY PETER LOH; LOH ET AL.; SINGLE PULSE IRREVERSIBLE ELECTROPORATION PVI. BACKGROUND - IRREVERSIBLE ELECTROPORATION (IRE) IS A PROMISING NEW NON-THERMAL ABLATION TECHNOLOGY FOR PULMONARY VEIN (PV) ISOLATION IN PATIENTS WITH ATRIAL FIBRILLATION (AF). EXPERIMENTAL DATA SUGGEST THAT IRE ABLATION PRODUCES LARGE ENOUGH LESIONS WITHOUT THE RISK OF PV STENOSIS, ARTERY, NERVE OR ESOPHAGEAL DAMAGE. THIS STUDY AIMED TO INVESTIGATE THE FEASIBILITY AND SAFETY OF SINGLE PULSE IRE PV ISOLATION IN PATIENTS WITH AF. TEN PATIENTS WERE INVOLVED IN THIS FIRST-IN-HUMAN STUDY, ACUTE BIDIRECTIONAL ELECTRICAL PV ISOLATION COULD BE ACHIEVED SAFELY BY SINGLE PULSE IRE ABLATION. TWO PATIENTS EXPERIENCED STROKE SYMPTOMS POST PROCEDURE AND BOTH RECOVERED COMPLETELY AND WERE DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036563 AGILIS INTRODUCER, UNKNOWN INTRODUCER, CATHETER DYB ST. JUDE MEDICAL, COSTA RICA LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other