BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    MDR report key: 2120281 · Received June 7, 2011

    Report

    Report Number
    3005188751-2011-00087
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AFTER THE TRANSSEPTAL PUNCTURE, WITH A SJM BRK NEEDLE, A SMALL PERICARDIAL EFFUSION WAS NOTED ON AN INTRA CARDIAC ECHOCARDIOGRAPHY (ICE). WHEN THE PHYSICIAN STARTED THE TRANSSEPTAL PUNCTURE TECHNIQUE, HE NOTED THE HEART WAS ROTATED AND ENLARGED. THE PHYSICIAN DECIDED TO CONTINUE THE CASE AND ADMINISTERED HEPARIN. THE SAFIRE BLU CATHETER WAS ADVANCED AND THE PHYSICIAN BEGAN TO MAP THE GEOMETRY OF THE LEFT ATRIUM. HE ABLATED FOR APPROXIMATELY 10 MINUTES AND NOTED A SLIGHT DROP IN BLOOD PRESSURE. THE PHYSICIAN CHECKED WITH ICE AND NOTED THE EFFUSION WAS NOW MODERATE. THE ABLATION CATHETER WAS REMOVED, HEPARIN WAS REVERSED AND A PERICARDIOCENTESIS WAS PERFORMED WITH 350 CC OF FLUID REMOVED. THE PT LEFT THE ROOM STABLE AND COMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK 1, 71CM BRK NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SAFIRE BLUE CATHETER, REORDER (B)(4), LOT 3294499