BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE

    MDR report key: 3850456 · Received May 16, 2014

    Report

    Report Number
    3005188751-2014-00074
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC (AF-MINNETONKA)
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION PROCEDURE WHEN PERFORMING TRANSSEPTAL PUNCTURE WITH A SJM BRK NEEDLE, THE RIGHT CORONARY CUSP WAS PUNCTURED. THE PT WAS STABLE AND NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS THEN CANCELLED. THE PHYSICIAN BELIEVED THE EVENT WAS DUE TO POOR IMAGING ISSUES WITH A NON-SJM ICE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293953 TRANSSEPTAL NEEDLE BRK SERIES DRC ST. JUDE MEDICAL, INC (AF-MINNETONKA) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1