BEUDAMED
    FDA Adverse Event Death Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 16942004 · Received May 16, 2023

    Report

    Report Number
    3005334138-2023-00206
    Event Type
    Death
    Date Received
    May 16, 2023
    Report Date
    June 16, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 INCIDENTS REMAIN UNKNOWN.

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE: TRANSSEPTAL NEEDLE, BRK SERIES.

    Description of Event or Problem · 0

    RELATED MANUFACTURE REF: 3008452825-2023-00201. THE FOLLOWING WAS PUBLISHED IN THE HEART RHYTHM 20.5: 680-688. ELSEVIER B.V. (MAY 2023) IN AN ARTICLE TITLED "VERY LONG TERM OUTCOMES OF ATRIAL FIBRILLATION ABLATION", WINKLE, ROGER. THE PURPOSE OF THIS STUDY WAS TO EVALUATE VERY LONG TERM AF ABLATION OUTCOMES. SUBJECTS WERE CONSECUTIVE PATIENTS UNDERGOING AF ABLATION FROM (B)(6) 2003, TO (B)(6) 2021. 5200 PATIENTS WERE FOLLOWED UNDERGOING 7145 ABLATION PROCEDURES. WE EVALUATED OUTCOMES AFTER SINGLE AND MULTIPLE ABLATION PROCEDURES FOR PAROXYSMAL (PAF; 33.6%), PERSISTENT (PEAF;56.4%), AND LONG-STANDING (LSAF; 9.9%) AF. WE COMPARED 3 ABLATION ERAS BY INITIAL ABLATION CATHETER: EARLY (101 PATIENTS) USING SOLID BIG TIP (SBT) CATHETERS (OCTOBER 2003 TO DECEMBER 2005), INTERMEDIATE (2143 PATIENTS) USING OPEN IRRIGATED TIP (OIT) CATHETERS (DECEMBER 2005 TO AUGUST 2016), AND CONTEMPORARY (2956 PATIENTS) USING CONTACT FORCE (CF) CATHETERS ((B)(6) 2014 TO (B)(6) 2021) THE FOLLOWING COMPLICATIONS OCCURRED: AN ATRIOESOPHAGEAL FISTULA RESULTING IN DEATH, A STROKE RESULTING IN DEATH, TAMPONADE (SOME REQUIRING SURGERY AND SOME REQUIRING A PERICARDIOCENTESIS) AND PULMONARY VEIN STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705837 TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿ CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown