BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN

    MDR report key: 15752362 · Received November 8, 2022

    Report

    Report Number
    2182269-2022-00056
    Event Type
    Injury
    Date Received
    November 8, 2022
    Report Date
    January 31, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    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

    ADDITIONAL INFORMATION REVEALED THE INITIAL MDR FOR THIS EVENT WAS REPORTED UNDER THE INCORRECT MFR REPORT # AND MANUFACTURING SITE. CORRECTED MANUFACTURING SITE INFORMATION HAS BEEN PROVIDED IN G1. THE CORRECT MFR NUMBER IS 2030404.

    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 PERICARDIAL EFFUSION/TAMPONADE AND VASCULAR ACCESS COMPLICATIONS REMAIN UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 3008452825-2022-00671, 3005334138-2022-00605, 3005334138-2022-0060. THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF CARDIOVASCULAR DEVELOPMENT AND DISEASE TITLED: "INCIDENCE OF LONG-TERM PULMONARY VEIN RECONNECTION AFTER A 2-MINUTES CRYOBALLOON FREEZE FOR PULMONARY VEIN ISOLATION¿INVASIVE INSIGHTS OF TTI-DEPENDENT CRYOENERGY TITRATION", J. CARDIOVASC. DEV. DIS. 2022, 9, 284. HTTPS://DOI.ORG/10.3390/JCDD9090284, ALEXANDER POTT, MD. CONSECUTIVE PATIENTS WITH AF RECURRENCE WHO UNDERWENT A SECOND AF ABLATION PROCEDURE AFTER INITIAL CRYOBALLOON PVI AT ULM UNIVERSITY MEDICAL CENTER WERE INCLUDED. INITIAL CRYOABLATION WAS PERFORMED EITHER BY A FIXED PROTOCOL OR A TTI-GUIDED PROTOCOL WRITTEN INFORMED CONSENT WAS OBTAINED FROM EACH PATIENT PRIOR TO THE PROCEDURE AND THE PROTOCOL WAS APPROVED BY OUR LOCAL ETHICS COMMITTEE. THE INVESTIGATION CONFORMED WITH THE PRINCIPLES OUTLINED IN THE DECLARATION OF HELSINKI. THE EXCLUSION CRITERIA WERE LA DIAMETER OF >60 MM, UNCONTROLLED HEART FAILURE (NYHA CLASS IV) AND SEVERE VALVULAR DISEASE. FOUR PERICARDIAL EFFUSIONS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250795 THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL, INC. (AF-MINNETONKA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other