BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION¿ SPIRAL EP CATHETER

    MDR report key: 8657824 · Received May 31, 2019

    Report

    Report Number
    2182269-2019-00075
    Event Type
    Injury
    Date Received
    May 31, 2019
    Report Date
    May 31, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: TACTICATH QUARTZ CATHETER, THERAPY COOL FLEX CATHETER, EVENT DATE UNKNOWN. 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. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2019-00083, 2030404-2019-00037. THE FOLLOWING WAS PUBLISHED IN HEART AND VESSELS IN AN ARTICLE TITLED ¿COMPARISON BETWEEN NOVEL AND STANDARD HIGH-DENSITY 3D ELECTRO-ANATOMICAL MAPPING SYSTEMS FOR ABLATION OF ATRIAL TACHYCARDIA BY MAURY P, CHAMP-RIGOT L, ROLLIN A, WATTS T, ET AL., 09 NOVEMBER 2018. ¿SIXTY CONSECUTIVE ATRIAL TACHYCARDIA ABLATION PROCEDURES USING ULTRA-HIGH-DENSITY MAPPING (GROUP 1) WERE RETROSPECTIVELY COMPARED TO 60 CONSECUTIVE PROCEDURES USING STANDARD HIGH-DENSITY MAPPING (GROUP 2). MINOR COMPLICATIONS (NON-SURGICAL VASCULAR COMPLICATIONS OR ASYMPTOMATIC PERICARDIAL EFFUSIONS) OCCURRED IN 15 PATIENTS.¿ (HTTPS://DOI.ORG/10.1007/S00380-018-1307-1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451743 REFLEXION¿ SPIRAL EP CATHETER ELECTROPHYSIOLOGY (STEERABLE) DRF ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other