BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2211910 · Received August 10, 2011

    Report

    Report Number
    3005188751-2011-00139
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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 WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED AIR WAS ASPIRATED FROM THE VALVE OF THE NEEDLE FOLLOWING TRANSSEPTAL PUNCTURE, PRIOR TO INSERTION OF THE SHEATH INTO THE LEFT ATRIUM. A NEW NEEDLE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PT.

    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 3377884

    Patients

    Seq Age Sex Outcome Treatment
    1