BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER

    MDR report key: 18888531 · Received March 12, 2024

    Report

    Report Number
    2030404-2024-00022
    Event Type
    Death
    Date Received
    March 12, 2024
    Report Date
    April 10, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE FIELD CONFIRMED THAT NO ABBOTT DEVICE WAS INVOLVED IN THE REPORTED ADVERSE EVENTS, MAKING THIS EVENT NOT REPORTABLE.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REFERENCE: 2030404-2024-00021, 2030404-2024-00023, 2030404-2024-00024. THE FOLLOWING WAS PUBLISHED IN AGING AND DISEASE 15.1: 408-420. INTERNATIONAL SOCIETY ON AGING AND DISEASE. (JAN 1, 2024). "INDEX AND REPEAT ABLATION FOR ATRIAL FIBRILLATION IN OLDER VERSUS YOUNGER PATIENTS: A PROPENSITY-SCORE MATCHING ANALYSIS"; ANA ISABEL MOLINA-RAMOS. THE ELECTROPHYSIOLOGICAL STUDY AND CATHETER ABLATION PROCEDURE FOR AF WERE PERFORMED UNDER DEEP SEDATION WITHOUT THE NEED FOR GENERAL ANESTHESIA USING A COMBINATION OF MIDAZOLAM, FENTANYL AND PROPOFOL. THE CATHETER ABLATION PROCEDURE INCLUDED TWO MAIN TECHNIQUES, RF AND CB. THE RF ABLATION WAS CONDUCTED WITH CARTO (BIOSENSE WEBSTER, IRVINE, CA, USA) AND NAVX (ENDOCARDIAL SOLUTIONS, SAINT PAUL, MN, USA) GUIDANCE SYSTEMS, WITH THE CORRESPONDING OPEN-IRRIGATED ABLATION CATHETERS AND UPDATES THROUGHOUT THE DURATION OF THE STUDY: THERMOCOOL AND THERMOCOOL SMARTTOUCH (BIOSENSE, WEBSTER, IRVINE, CA, USA); THERAPY COOL PATH AND THERAPY COOL FLEX (ABBOT, CHICAGO, IL, USA). THE CB TECHNIQUE WAS EXCLUSIVELY A SINGLE-SHOT ABLATION OF THE PV OSTIUM WITH 240-MS APPLICATIONS AT -40 DEGREES CELSIUS USING ARCTIC FRONT AND ARCTIC FRONT ADVANCE CATHETERS (MEDTRONIC, MINNEAPOLIS, MN, USA). PHRENIC STIMULATION WAS PERFORMED TO MONITOR NERVE INJURY. A CT SCAN WAS PREVIOUSLY PERFORMED TO ASSESS THE ANATOMY OF THE PVS. FOR MORE DETAILS SEE MOLINA-RAMOS ET AL. [13]. THE TOTAL DURATION OF THE FOLLOW-UP WAS 30 MONTHS FROM THE INDEX ABLATION PROCEDURE. PATIENTS WERE FOLLOWED UP IN THE OUTPATIENT CLINIC AT 3, 6, 12, 18, 24 AND 30 MONTHS BY A CARDIOLOGIST. AT EACH FOLLOW-UP TIME POINT, PATIENTS HAD AN ELECTROCARDIOGRAM AND A HOLTER MONITOR FOR 24 H OR SEVEN DAYS DEPENDING ON THE FREQUENCY OF SYMPTOMS. 1 PERICARDIAL TAMPONADE RESULTING IN DEATH AND 1 ATRIOESOPHAGEAL FISTULA RESULTING IN DEATH WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725304 THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death THERAPY¿ COOL FLEX¿ ABLATION CATHETER| THERAPY¿ COOL FLEX¿ ABLATION CATHETER| THERAPY¿ COOL PATH¿ DUO ABLATION CATHETER