BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDCH 5, 110, RA/RA CATHETER KIT

    MDR report key: 1833091 · Received May 11, 2010

    Report

    Report Number
    2025816-2010-00046
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    November 10, 2009
    Report Date
    November 18, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REC'D REPORTING BALLOON INFLATION FAILURE WITH ONE (1) 41233-01, THERMODILUTION CATHETER. IT WAS REPORTED THAT "PRIOR TO PLACEMENT, BALLOON WAS TESTED AND INTACT. IMMEDIATELY AFTER PLACEMENT, BALLOON WAS INFLATED AND WEDGE PRESSURE WAS OBTAINED. ON (B)(6) 2009, MEDICAL AND NURSING STAFF WERE UNABLE TO OBTAIN WEDGE PRESSURE FROM THERMODILUTION CATHETER...UPON REMOVAL, NURSE NOTED THAT BALLOON HAD RUPTURED." THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCES. MANUFACTURER'S INVESTIGATION AND ANALYSIS: ONE (1) 41233-01 CATHETER WAS RECEIVED AND PROCESSED AT THE ICU MEDICAL (B)(4)FACILITY. THE INVESTIGATION IS SUMMARIZED BELOW: VISUAL INSPECTION AND ANALYSIS WAS PERFORMED. THE CATHETER BALLOON WAS EXAMINED UNDER A MICROSCOPE AT 10X MAGNIFICATION. THE RESULTS RECORDED THAT THE CATHETER BALLOON MATERIAL WAS INDEED TORN/DAMAGED. CONCLUSION: ALTHOUGH THE EXACT CAUSE(S) OF THE BALLOON TEARS/DAMAGES ARE UNKNOWN, THE ENGINEERING ANALYSIS REPORT CITES THIS TYPE OF DAMAGE HAS BEEN REPLICATED/CAN OCCUR AS A RESULT OF OVER-INFLATION OR PENETRATION WITH A SHARP INSTRUMENT/OBJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDCH 5, 110, RA/RA CATHETER KIT PA CATHETER DYG ICU MEDICAL, INC. 41233-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1