BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM

    MDR report key: 2130481 · Received June 13, 2011

    Report

    Report Number
    3005188751-2011-00097
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSSEPTAL PUNCTURE, THE PHYSICIAN PERFORATED THROUGH THE HEART WALL WITH THE BRK NEEDLE; NO EPICARDIAL EFFUSION WAS NOTED. NO FURTHER CONSEQUENCES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM TRANSSEPTAL BRK NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407200 3306005

    Patients

    Seq Age Sex Outcome Treatment
    1 SUPREME EP CATHETER, HEX - REORDER (B)(4)| BARD VIKING AND DYNAMIC DECA| BIOSENSE WEBSTER THERMOCOOL| SUPREME EP CATHETER, JSN - REORDER (B)(4)