BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z-5 ATRIOSEPTOSTOMY CATHETER

    MDR report key: 1930225 · Received November 18, 2010

    Report

    Report Number
    9618000-2010-00010
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 5, 2010
    Report Date
    November 17, 2010
    Manufacturer
    NUMED CANADA, INC.
    Product Code
    DQO
    PMA / PMN Number
    K960070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BALLOON RUPTURED ON THE 4TH INFLATION. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS NOT USED AS SPECIFIED IN THE INSTRUCTIONS FOR USE. THE PHYSICIAN USED A SYRINGE, WHICH DOES NOT ALLOW THE PHYSICIAN TO MONITOR THE INFLATION PRESSURE DURING USE. THIS CAN CAUSE THE DEVICE TO BE TAKEN ABOVE THE LABELED RATED BURST PRESSURE. TWO DEVICE FROM INVENTORY WERE PULLED AND TESTED FOR RBP. THE LABELED RBP FOR THIS DEVICE IS 2.0 ATM. ONE DEVICE BURST AT 8.0 ATM AND THE OTHER ONE AT 8.5 ATM, WHICH IS WELL ABOVE THE LABELED RBP.

    Description of Event or Problem · 1

    BALLOON BURST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-5 ATRIOSEPTOSTOMY CATHETER SEPTOSTOMY CATHETER DQO NUMED CANADA, INC. 210 AS-1067

    Patients

    Seq Age Sex Outcome Treatment
    1