BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 1421653 · Received July 24, 2009

    Report

    Report Number
    3005188751-2009-00038
    Event Type
    Injury
    Date Received
    July 24, 2009
    Date of Event
    July 16, 2009
    Report Date
    July 21, 2009
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ST. JUDE MEDICAL AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. THE CAUSE OF THE REPORTED TAMPONADE REMAINS UNKNOWN. IT SHOULD BE NOTED THAT THE PHYSICIAN DOES NOT ALLEGE A DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A TAMPONADE DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. CPR WAS ADMINISTERED AND A PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN HAD DIFFICULTY WITH THE TRANSSEPTAL IN THAT HE SAW CONTRAST IN THE AORTA SO HE IS NOT SURE WHAT CAUSED THE TAMPONADE; WHETHER IT WAS DURING THE TRANSSEPTAL OR DURING ABLATION. THE PT'S CONDITION WAS STABLE AT THE END OF THE PROCEDURE. THE PHYSICIAN DOES NOT ALLEGE A DEVICE MALFUNCTION ASSOCIATED WITH THE EVENT. THE FOLLOWING DEVICES WERE USED DURING THE PROCEDURE. A BRK OR BRK-1 NEEDLE (UNKNOWN REORDER AND LOT - SJM FILE # BRK-09-0048) AND THE COOL PATH DUO CATHETER WERE USED ON THE LEFT SIDE OF THE HEART. ALSO USED IN THE PROCEDURE, BUT NOT ON THE LEFT SIDE WERE TWO ST JUDE MEDICAL SL-1 SHEATHS (MODEL 407439, LOT UNKNOWN), A BOSTON CS CATHETER AND A RV CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK SERIES BRK NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK