BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 2259137 · Received September 19, 2011

    Report

    Report Number
    3005188751-2011-00168
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ST. JUDE MEDICAL AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. A DHR REVIEW WAS NOT POSSIBLE AS THE SERIAL/ LOT NUMBER IS UNK. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE, A CARDIAC PERFORATION IN THE LEFT ATRIUM OCCURRED. THE PHYSICIAN ADVANCED A BRK-1 NEEDLE THROUGH AN AGILIS SHEATH AND WAS ATTEMPTING TO MAKE A TRANSSEPTAL PUNCTURE WHEN THE PERFORATION OF THE LEFT ATRIUM OCCURRED. A DUO DECA CATHETER WAS IN THE RIGHT ATRIUM AND A SUPREME 5F QUAD JSN DIAGNOSTIC CATHETER WAS IN THE RIGHT VENTRICLE. A THERAPY COOL PATH CATHETER WAS THEN ADVANCED AND WAS BEING USED TO ISOLATE THE LEFT PULMONARY VEINS. THE PERFORATION WAS NOTED AS THE PT WAS BEING ANTICOAGULATED AND A DROP IN BLOOD PRESSURE WAS NOTED. THE PROCEDURE WAS NOT COMPLETED AND HAS NOT BEEN SCHEDULED AT THE TIME OF THE REPORTING. THE PT HAS RECOVERED AND IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention SUPREME 5FR QUAD JSN DIAGNOSTIC CATHETER LOT# UNK| BOSTON SCIENTFIC DOU DECA CATHETER LOT # UNK| THERAPY COOLPATH CATHETER LOT NUMBER UNK| AGILIS SHEATH LOT NUMBER UNK| WORKMATE RECORDING SYSTEM, CPU (B)(4)