BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER

    MDR report key: 18553137 · Received January 22, 2024

    Report

    Report Number
    3008452825-2024-00047
    Event Type
    Injury
    Date Received
    January 22, 2024
    Report Date
    March 6, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 STENOSIS REMAINS UNKNOWN.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY 34.12: 2417-2424. JOHN WILEY AND SONS INC. (DEC 2023) IN AN ARTICLE TITLED "COMPARISON OF PULSED-FIELD ABLATION VERSUS VERY HIGH POWER SHORT DURATION-ABLATION FOR PULMONARY VEIN ISOLATION", WÖRMANN, JONAS; DOI: 10.1111/JCE.16101. THIS STUDY SOUGHT TO INVESTIGATE EFFICACY AND PROCEDURAL DIFFERENCES FOR PFA-PVI VERSUS VHPSD-PVI IN PATIENTS UNDERGOING DE NOVO ABLATION IN THE SETTING OF PAF AND PERSAF, BETWEEN SEPTEMBER 2021 AND OCTOBER 2022 ALL CONSECUTIVE PATIENTS UNDERGOING DE NOVO PFA-PVI FOR SYMPTOMATIC PAF OR PERSAF WERE INCLUDED IN THIS RETROSPECTIVE ANALYSIS AND MATCHED TO PATIENTS RECEIVING VHPSD-PVI DURING THE SAME PERIOD AT OUR CENTER. EXCLUSION CRITERIA WERE AN AGE OF <18 YEARS, PREVIOUS LEFT ATRIAL ABLATION, AND LACK OR WITHDRAWAL OF WRITTEN INFORMED CONSENT. DATA ACQUISITION WAS PERFORMED USING AN ELECTRONIC CASE REPORT FORM (CRF) (REDCAP DATABASE). THE TRIAL COMPLIED WITH THE DECLARATION OF HELSINKI, THE LOCAL ETHICS COMMITTEE APPROVED THE PROTOCOL AND ALL PATIENTS PROVIDED WRITTEN INFORMED CONSENT FOR THE PROCEDURE, GENERAL DATA ACQUISITION, PROCESSING, AND ANALYSIS. ONE PATIENT EXPERIENCED A SUBCLINICAL PULMONARY VEIN STENOSIS OF THE LEFT SUPERIOR PULMONARY VEIN DURING A REDO-ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395971 FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other