BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F TD CATHETER

    MDR report key: 4729698 · Received April 14, 2015

    Report

    Report Number
    2025816-2015-00032
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    January 17, 2015
    Report Date
    March 2, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: VISUAL ASSESSMENT OF THE "AS-RECEIVED" USED 41232-02 CATHETER DEVICE RECORDED BALLOON COMPONENT DAMAGES. THE CATHETER DEVICE WAS PRETESTED FOR INFLATION INTEGRITY. THE ENGINEERS EVALUATION OF THE RETURNED CATHETER/BALLOON DETERMINED THE CAUSE(S) OF THE BALLOON COMPONENT DAMAGES WERE DUE TO INCORRECT USAGE/OVER­ INFLATION. THE INVESTIGATION FINDINGS WILL BE PROVIDED TO THE REPORTING FACILITY FOR THEIR REVIEW AND INFORMATION.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING BALLOON INFLATION FAILURE WITH USE OF ONE 41232-02 SF TD CATHETER 5 LUMEN, 110 CM, RA/RV HEPARIN COATED, LF. IT WAS REPORTED THAT FOLLOWING PRE-TESTING/SET-UP ATTENDING CLINICIAN WAS ".. DEMONSTRATING HOW TO WEDGE A SWAN GANZ CATHETER TO MY ORIENTEE AND UPON INFLATION OF THE BALLOON HEARD A "POPPING" SOUND.... THE PATIENT WAS ALERT AND ORIENTED TO 3 WITH STABLE VITAL SIGNS .. DID NOT SHOW ANY .. SYMPTOMS OF DISCOMFORT. THE SWAN WAVEFORM REMAINED IN (B)(6) AND THE FELLOW, AND THE ATTENDING PHYSICIAN WERE NOTIFIED. DR. EXAMINED THE PATIENT AND REMOVED THE SWAN WITHOUT DIFFICULTY. NO INJURY" DEVICE RETURN: ONE (1) USED 41232-02 CATHETER; UNK. CONTAMINATION SHEATH; 10ML BD SYRINGE. MFR'S INVESTIGATION: VISUAL ANALYSIS OF THE "AS-RECEIVED" USED 41232-02 TD CATHETER RECORDED DAMAGES/TEARS TO THE CATHETER DEVICE BALLOON COMPONENT BLOOD WAS ALSO OBSERVED INSIDE THE BALLOON LUMEN. NO OBVIOUS DEFECTS NOTED WITH THE 10ML BD SYRINGE THAT WAS MATED/ATTACHED TO THE BALLOON LINE. ENGINEERING EVALUATION: VISUAL ASSESSMENT OF THE RETURNED CATHETER BALLOON UNDER MAGNIFICATION DOCUMENTED THE CHARACTERISTICS OF THE TEARS/BALLOON DAMAGES WERE CONSISTENT WITH OVER INFLATION. THE 41232-02 CATHETER DEVICE /KIT IS SUPPLIED WITH A 1.5ML STAKED SYRINGE TO ENSURE INFLATION ACCURACY AND THAT INFLATION CAPACITY IS NOT EXCEEDED. THE ENGINEERS REPORT CONCLUDED THAT USING A 10ML SYRINGE WOULD BE DIFFICULT TO CONTROL THE PRECISE INFLATION VOL. REQUIRED AND COULD EASILY RESULT IN OVERINFLATING/DAMAGING THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246633 8F TD CATHETER CATHETER DYG ICU MEDICAL, INC. 41232-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI