BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 6230121 · Received January 6, 2017

    Report

    Report Number
    3005831739-2017-00001
    Event Type
    Injury
    Date Received
    January 6, 2017
    Report Date
    January 4, 2017
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND AN INVESTIGATION WAS PERFORMED ON 1/3/17. THE INVESTIGATION RESULTS CONFIRMED THE CONDITION REPORTED. THE WIRE ON THE DEVICE DID NOT BREAK. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND FUNCTIONED PROPERLY IN ALL SETTINGS. THERE WERE NO FUNCTIONAL FAILURES. THE ROOT CAUSE WAS DETERMINED TO BE "OPERATOR ERROR". THE DEVICE WAS ADVANCED BACK INTO THE VEIN WITH THE CATHETER ASSEMBLY MATED TO THE MDU AND IN POSITION 2, THE MOTOR RUNNING, AND DISPERSION WIRE TIP SPINNING THUS TANGLING THE VEIN. IN THE "CAUTIONS" SECTION OF THE CLARIVEIN IFU IT STATES "DO NOT ADVANCE THE CATHETER ASSEMBLY WHEN THE CATHETER ASSEMBLY CARTRIDGE IS MATED TO THE MDU AND IS IN POSITION 2.

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING AN INFUSION PROCEDURE USING THE CLARIVEIN INFUSION CATHETER AND TREATED ABOUT 6- 10 CM. OF THE VEIN. THE PHYSICIAN PERCEIVED A PROBLEM WITH MOTOR SOUND AND SO PUSHED THE CATHETER BACK UP THE VEIN WHILE THE TIP ACTIVELY SPINNING. THE CATHETER TIP BECAME STUCK. THE PHYSICIAN WAS NOT ABLE TO FREE THE DEVICE BY PULLING DOWN. HE SURGICAL EXPOSED, CUT AND REMOVED THE TIP THUS FREEING THE MAIN SHAFT OF CATHETER TO BE PULLED THROUGH THE ACCESS POINT FROM THE PATIENT'S VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14498 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC 65-018-E4S BM651401316I

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention