BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD TORQUE LINE CATHETER

    MDR report key: 5998636 · Received October 4, 2016

    Report

    Report Number
    2025816-2016-00141
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    May 18, 2016
    Report Date
    June 8, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    K832957
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RECORD REVIEW A REVIEW OF THE MFG. LOT DATABASE FOR THE REPORTED LOT# 61-139-JW (MFG. 01/2016) SHOWED (B)(4) UNITS WERE MFG., TESTED, INSPECTED & RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. ALTHOUGH REQUESTED THE INVOLVED DEVICE AND OR SAME LOT SAMPLES HAVE NOT BEEN RETURNED FOR ANALYSIS AND CONFIRMATION. DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    MEDSUN REPORT RECEIVED CONCERNING INFLATION ISSUE WITH ONE 41231-05 7F TD TORQUE-LINE CATHETER. THE MEDSUN REPORT DESCRIBES THE EVENT AS FOLLOWS "...DOCTOR INSERTED DEVICE AS PER USE. UPON BALLOON INFLATION IN THE PULMONARY ARTERY, THE BALLOON WASN'T VISIBLE UNDER FLUOROSCOPY. IT WAS SUGGESTED TO SEE IF THERE WAS BLOOD IN THE BALLOON PORT AND THERE WAS BLOOD FOUND. DEVICE WAS SWITCHED OUT FOR A SIMILAR SWAN WITH NO FURTHER ISSUES. PRESSURES WERE OBTAINED AND PATIENT WENT TO RECOVERY ROOM FOR DISCHARGE AFTER 4 HRS. NO ADVERSE OUTCOME WAS ENCOUNTERED.". ADDITIONAL INFORMATION AS WELL AS THE STATUS/AVAILABILITY OF THE INVOLVED DEVICES HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648081 TD TORQUE LINE CATHETER TD TORQUE LINE CATHETER DYG ICU MEDICAL, INC. 41231-05 61-139-JW

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR