BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD 5 LUMEN HEPARIN COATED CATHETER

    MDR report key: 5338907 · Received December 31, 2015

    Report

    Report Number
    2025816-2015-00154
    Event Type
    Malfunction
    Date Received
    December 31, 2015
    Date of Event
    August 23, 2015
    Report Date
    November 10, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    K832957
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: ONE USED 41232-02 8F TD CATHETER W/ ARROW 8 F TOUCH CONTAMINATION SHIELD. QE INVESTIGATION AND ANALYSIS: VISUAL INSPECTION AND ANALYSIS OF THE "AS-RECEIVED" 41232-02 8F TD CATHETER IDENTIFIED VARIOUS STRESS MARKS/TEARS/DAMAGES TO THE CATHETER BALLOON COMPONENT. ENGINEERING ASSESSMENT OF THE CHARACTERISTICS OF THIS TYPE OF COMPONENT DAMAGE CONCLUDED INCORRECT TECHNIQUE/USAGE CONDITIONS CAUSED AND OR CONTRIBUTED THE BALLOON DAMAGE. AS THE 41232-02 CATHETER WAS PRE-INSERTION TESTED WHICH INCLUDES INFLATION TESTING PRIOR TO PLACEMENT, THIS TYPE OF COMPONENT DAMAGE WOULD HAVE BEEN READILY APPARENT AND RENDERED THE DEVICE UNUSABLE. PREVIOUS INVESTIGATIONS HAVE IDENTIFIED CATHETER BALLOON DAMAGES CAN OCCUR IF USING INCORRECT SIZED ACCESSORY DEVICES, OR IF CARE IS NOT TAKEN WHILE ADVANCING THE CATHETER THROUGH HEMOSTASIS VALVES OF TOUCH CONTAMINATION SHIELDS AND OR SHEATHS OF INTRODUCERS. THE CATHETER DIRECTION FOR USE (DFU'S) PROVIDES DETAILS ON ACCESSORY DEVICE SIZE REQUIREMENTS AND INSTRUCTIONS. THE DFU IDENTIFIES THE 41232-02 8F TD CATHETERS REQUIRES SIZE 8.5 F OR LARGER ANCILLARY DEVICES (INTRODUCERS/CONTAMINATION SHIELD). ADDITIONALLY THE DFU INSTRUCTIONS ALSO ADVISE TO RETEST THE BALLOON FOR PROPER FUNCTION AFTER INSERTION THROUGH THE SHIELD. FINDINGS: VISUAL ASSESSMENT OF THE "AS-RECEIVED" USED 41232-02 8F CATHETER DEVICE CONFIRMED THE REPORTED INFLATION ISSUE. THE ROOT CAUSE WAS ATTRIBUTABLE COMPONENT DAMAGE(S) THAT MOST LIKELY WERE A RESULT OF INCORRECT USAGE/TECHNIQUE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED REPORTING INFLATION ISSUE WITH USE OF ONE 41232-02 TD 8F TD CATHETER, 5 LUMEN, 110CM, RA/RV, HEPARIN COATED, LF. THE REPORT DESCRIBES THE (B)(6) 2015 EVENT AS FOLLOWS" PATIENT HAD A SWAN GANZ CATHETER IN-WHICH FICK CALCULATIONS WERE DUE FOR 06:00 AM....THE PATIENT'S RN WAS INFLATING THE SWAN BALLOON AS HAD BEEN DONE ON NUMEROUS PREVIOUS ACCOUNTS WITHOUT ISSUES. AS BALLOON WAS INFLATING, CATHETER BALLOON RUPTURED AND BLOOD WAS NOTED IN THE BALLOON TUBING. .. HAD NOT REACHED A WEDGE PRESSURE SO BALLOON RUPTURE WAS NOT DUE TO OVER INFLATION AS IT RUPTURED WITH ONLY L.3ML OF AIR INSTILLED. CATHETER BALLOON WAS ALWAYS PASSIVELY DEFLATED SO THIS WAS NOT THE CAUSE OF RUPTURE. BALLOON WAS NOT OVER INFLATED SO THLS WAS ALSO NOT THE ISSUE. ....". THE CATHETER DEVICE WAS REMOVED AND REPLACED WITH NO FURTHER ISSUES ENCOUNTERED. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES AND OR CONSEQUENCES. THIS IS THE MANUFACTURERS FOLLOW UP REPORT TO PROVIDE ADDITIONAL INFORMATION (DEVICE RETURN) AND INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED REPORTING INFLATION ISSUE WITH USE OF ONE 41232-02 TD 8F TD CATHETER, 5 LUMEN, 110CM, RA/RV, HEPARIN COATED, LF. THE REPORT DESCRIBES THE (B)(6) 2015 EVENT AS FOLLOWS " PATIENT HAD A SWAN GANZ CATHETER IN-WHICH FICK CALCULATIONS WERE DUE FOR 06:00 AM....THE PATIENT'S RN WAS INFLATING THE SWAN BALLOON AS HAD BEEN DONE ON NUMEROUS PREVIOUS ACCOUNTS WITHOUT ISSUES. AS BALLOON WAS INFLATING, CATHETER BALLOON RUPTURED AND BLOOD WAS NOTED IN THE BALLOON TUBING. .. HAD NOT REACHED A WEDGE PRESSURE SO BALLOON RUPTURE WAS NOT DUE TO OVER INFLATION AS IT RUPTURED WITH ONLY L.3ML OF AIR INSTILLED. CATHETER BALLOON WAS ALWAYS PASSIVELY DEFLATED SO THIS WAS NOT THE CAUSE OF RUPTURE. BALLOON WAS NOT OVER INFLATED SO THLS WAS ALSO NOT THE ISSUE. ....". THE CATHETER DEVICE WAS REMOVED AND REPLACED WITH NO FURTHER ISSUES ENCOUNTERED. THERE WERE NO REPORTED ADVERSE PATIENT OUTCOMES AND OR CONSEQUENCES. MFR. HAS MADE MULTIPLE REQUESTS FOR ADDITIONAL EVENT/USAGE INFORMATION AS WELL AS DEVICE RETURN STATUS. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862021 TD 5 LUMEN HEPARIN COATED CATHETER TD 5 LUMEN HEPARIN COATED CATHETER DYG ICU MEDICAL, INC. 41232-02 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR