BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE¿ BLU¿ ABLATION CATHETER

    MDR report key: 8974937 · Received September 9, 2019

    Report

    Report Number
    2030404-2019-00090
    Event Type
    Injury
    Date Received
    September 9, 2019
    Report Date
    September 9, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER IS UNAVAILABLE. BASED ON THE INFORMATION PROVIDED TO ABBOTT, THE REPORTED ADVERSE EVENTS COULD NOT BE CONFIRMED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE. FURTHER INFORMATION REGARDING THE EVENT WERE REQUESTED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE: 2030404-2019-00091. THE FOLLOWING WAS PUBLISHED IN EUROPEAN PACING, ARRHYTHMIAS, AND CARDIAC ELECTROPHYSIOLOGY: JOURNAL OF THE WORKING GROUPS ON CARDIAC PACING, ARRHYTHMIAS, AND CARDIAC CELLULAR ELECTROPHYSIOLOGY OF THE EUROPEAN SOCIETY OF CARDIOLOGY IN AN ARTICLE TITLED ¿MULTICENTRE SAFETY OF ADDING FOCAL IMPULSE AND ROTOR MODULATION (FIRM) TO CONVENTIONAL ABLATION FOR ATRIAL FIBRILLATION" BY BAYKANER T, SCHRICKER AA, ET AL, 2017; 19(5):769-774. TWO PATIENTS HAD A STROKE OR TRANSIENT ISCHAEMIC ATTACK, 9 PATIENTS HAD TAMPONADE OR A PERICARDIAL DRAIN OCCUR, 2 PATIENTS HAD HEART BLOCK, 1 PATIENT HAD MYOCARDIAL INFARCTION. (DOI:10.1093/EUROPACE/EUW377).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769425 SAFIRE¿ BLU¿ ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other