BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 19294461 · Received May 10, 2024

    Report

    Report Number
    3008452825-2024-00263
    Event Type
    Injury
    Date Received
    May 10, 2024
    Report Date
    May 22, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P220013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY 67.3: 549-557. SPRINGER. (APR 2024) "HIGH-POWER SHORT-DURATION CATHETER ABLATION OF ATRIAL FIBRILLATION: IS IT REALLY A NEW ERA? COMPARISON BETWEEN NEW AND OLD RADIOFREQUENCY CONTACT FORCE¿SENSING CATHETERS"; DELLO RUSSO, ANTONIO, ET AL. WE CONDUCTED A PROSPECTIVE, OBSERVATIONAL, SINGLE-CENTRE STUDY INCLUDING 40 CONSECUTIVE PATIENTS UNDERGOING PVI FOR PAROXYSMAL/PERSISTENT AF, USING HPSD ABLATION WITH THE NOVEL TFSE CATHETER (HPSD/TFSE GROUP). BASED ON PROPENSITY SCORE-MATCHING, FORTY PATIENTS UNDERGOING SPLD PVI WITH THE TCSE CATHETER WERE IDENTIFED (SPLD/TCSE GROUP). IN THE HPSD/TFSE GROUP, RF LESIONS WERE PERFORMED BY DELIVERING 40¿50 W FOR 10¿20 S, WHILE IN THE SPLD/TCSE GROUP, RF POWER WAS 30¿35 W, TARGETING A LESION SIZE INDEX (LSI) OF 4.0¿5.5. THE CO-PRIMARY STUDY OUTCOMES WERE TIME REQUIRED TO COMPLETE PVI AND FRST PASS ISOLATION (FPI). PVI WAS ACHIEVED IN 100% OF PATIENTS IN BOTH GROUPS, AND NO MAJOR ADVERSE EVENTS WERE OBSERVED. REMARKABLY, PVI TIME WAS SHORTER IN THE HPSD/TFSE, COMPARED TO THE SPLD/TCSE GROUP, WHILE FPI RATE WAS NON-SIGNIFCANTLY HIGHER IN THE FORMER GROUP. SHORTER PROCEDURAL 108 MIN VS. 173 MIN, TOTAL RF 9 MIN VS. 43 MIN, FLUOROSCOPY TIMES 15 MIN VS. 18 MIN, AND LOWER DAP 1461 VS. 7200, WERE RECORDED IN THE HPSD/TFSE GROUP. A HIGHER AVERAGE IMPEDANCE DROP WAS OBTAINED WITH HPSD/TFSE CA 17 VS. 16. ONE PERICARDIAL EFFUSION WAS REPORTED WHICH WAS OBSERVED ON ECHOCARDIOGRAM AND RESOLVED SPONTANEOUSLY WITHOUT INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905601 TACTIFLEX¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening