BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F TD CATHETER

    MDR report key: 3666838 · Received November 5, 2013

    Report

    Report Number
    2025816-2013-00124
    Event Type
    Malfunction
    Date Received
    November 5, 2013
    Date of Event
    August 21, 2013
    Report Date
    August 22, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN STATUS: THE MANUFACTURERS REQUEST THAT THE 41232-01 8F CATHETER DEVICE BE RETURNED FOR ANALYSIS WAS DENIED PER HOSPITAL INTERNAL POLICY. A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT # 18-474-SL (MFG. DATE (09/2012) SHOWS 250 UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FOLLOW-UP INFORMATION FROM FACILITY IDENTIFIED AN 8FR INTRODUCER WAS USED WITH THE 41232-01 8FR CATHETER. THE 41232-01 8FR CATHETERS DIRECTION FOR USE (DFU) PROVIDES SPECIFIC INSTRUCTIONS FOR REQUIRED SIZED ACCESSORY DEVICES AND IDENTIFIES THIS CATHETER REQUIRES USE OF 8.5 F OR LARGER. CONCLUSION: THE INVOLVED 41232-01 8F CATHETER DEVICE WAS NOT RETURNED FOR ANALYSIS AND CONFIRMATION. ALTHOUGH THE EXACT CAUSE(S) OF THE CATHETER BALLOON INFLATION PROBLEM ARE UNKNOWN USE OF AN INCORRECT SIZE INTRODUCER SHEATH MOST LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED BALLOON TEAR.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED CONCERNING CATHETER BALLOON INFLATION ISSUE WITH USE OF ONE 41232-01 8F TD CATHETER. REPORT STATES, WHILE PERFORMING LEFT AND RIGHT HEART CATHETERIZATION ON PATIENT, THERMODILUTION CATHETER WAS ADVANCED VIA FEMORAL VENOUS ACCESS. CATHETER ADVANCED TO THE INFERIOR VENA CAVA AND WAS NOTED TO NOT BE INFLATABLE. CATHETER WAS REMOVED FROM SHEATH, AND NOTED TO HAVE RUPTURED AT SOME TIME BETWEEN TESTING INFLATION OF THE BALLOON PRIOR TO THE PROCEDURE AND ADVANCEMENT OF THE THERMODILUTION CATHETER INTO THE INFERIOR VENA CAVA. TIP OF THE THERMODILUTION CATHETER INTACT AND BALLOON REMAINED IN PLACE AT END OF CATHETER... VISUALIZATION OF CATHETER POST PROCEDURE NOTED BALLOON APPEARS INTACT BUT WITH OBVIOUS TEAR. PATIENT WAS OBSERVED FOLLOWING THE PROCEDURE.. NO ADVANCE EVENT OCCURRED THAT AFFECTED THE PATIENT." THE 41232-01 8F CATHETER WAS SUCCESSFULLY PRE-TESTED PRIOR TO PLACEMENT WHERE NO INFLATION ISSUES/ANOMALIES WERE ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572191 8F TD CATHETER TD CATHETER DYG ICU MEDICAL, INC. 41232-01 18-475-SL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR BOSTON SCIENTIFIC 8F X 11CM SUPER SHEATH