BEUDAMED
    FDA Adverse Event Death Summary report: N

    Z-MED PTV CATHETER

    MDR report key: 1408743 · Received June 29, 2009

    Report

    Report Number
    1318694-2009-00006
    Event Type
    Death
    Date Received
    June 29, 2009
    Date of Event
    January 28, 2009
    Report Date
    June 29, 2009
    Manufacturer
    NUMED, INC.
    Product Code
    LIT
    PMA / PMN Number
    K991977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    W.L. GORE REPORTED TO NUMED THAT A DEATH OCCURRED WHILE THEIR GORE EXCLUDER DEVICE WAS BEING IMPLANTED. THEY REPORTED THAT A Z-MED CATHETER WAS USED FOR THE PROCEDURE SO THEY WERE NOTIFYING NUMED ABOUT THE DEATH. IT IS UNKNOWN WHAT THE PATIENT DIED FROM OR IF NUMED'S DEVICE WAS RELATED IN ANY WAY TO THE DEATH REPORTED. IF THE Z-MED CATHETER WAS BEING USED TO IMPLANT THE GORE EXCLUDER DEVICE, IT WOULD BE AN OFF-LABEL USE. NUMED IS TRYING TO GET MORE INFORMATION RELATED TO THE DEATH, AND WILL SEND A FOLLOW-UP REPORT ONCE MORE INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-MED PTV CATHETER PTV CATHETER LIT NUMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1