BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARGON THERMODILUTION CATHETER

    MDR report key: 382001 · Received March 12, 2002

    Report

    Report Number
    MW1024394
    Event Type
    Other
    Date Received
    March 12, 2002
    Date of Event
    February 19, 2002
    Report Date
    March 12, 2002
    Manufacturer
    ARGON A DIV OF MIXXIM MED
    Product Code
    DYG
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BALLOON ON PULMONARY ARTERY CATHETER WOULD NOT DEFLATE AFTER INFLATION INSIDE PT. AFTER MULTIPLE ATTEMPTS, BALLOON DID DEFLATE AND CATHETER WAS REMOVED FROM PT. NO INJURY TO PT. THERMODILUTION CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON THERMODILUTION CATHETER PULMONARY ARTERY CATHETER DYG ARGON A DIV OF MIXXIM MED W.O. #J104260 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other