BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿

    MDR report key: 17490398 · Received August 9, 2023

    Report

    Report Number
    3005334138-2023-00346
    Event Type
    Injury
    Date Received
    August 9, 2023
    Report Date
    August 9, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAE
    PMA / PMN Number
    P130026
    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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    THE FOLLOWING WAS PUBLISHED IN JACC: CLINICAL ELECTROPHYSIOLOGY 9.6: 790-804. ELSEVIER INC. (JUN 2023) "ADVERSE PROGNOSIS OF PATIENTS WITH SEPTAL SUBSTRATE AFTER VT ABLATION DUE TO ELECTRICAL STORM"; MUELLER, JULIAN. IN THIS LARGE SINGLE-CENTER STUDY, CONSECUTIVE PATIENTS PRESENTING WITH ES AND UNDERGOING VT ABLATION FROM JUNE 2018 TO APRIL 2021 WERE INCLUDED. PATIENTS WITH SEPTAL SUBSTRATE WERE COMPARED WITH PATIENTS WITHOUT SEPTAL SUBSTRATE REGARDING ENDPOINTS OF CARDIOVASCULAR MORTALITY, VT RECURRENCES, RECURRENCES OF THE CLINICAL VT, AND REHOSPITALIZATION RATES. ABLATION-INDUCED POST-INTERVENTIONAL THIRD-DEGREE AV BLOCK OCCURRED IN 5 PATIENTS DURING ABLATION OF SEPTAL SUBSTRATE, ALL 5 PATIENTS HAD DOCUMENTED PRIOR AV-CONDUCTION DELAY/DISTURBANCES AND WERE PROTECTED BY DUAL OR BIVENTRICULAR PACING DEVICES. 3 CARDIOGENIC SHOCKS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543665 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 Life Threatening