BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 5386565 · Received January 22, 2016

    Report

    Report Number
    3005831739-2016-00001
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    December 16, 2015
    Report Date
    January 18, 2015
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ISSUES CITED WITH THE PERFORMANCE OF THE DEVICE. DEVICE NOT MADE AVAILABLE BY PHYSICIAN.

    Description of Event or Problem · 1

    PHYSICIAN USED THE CLARIVEIN CATHETER TO INFUSE PHYSICIAN SPECIFIED MEDICATION TO THE PERIPHERAL VASCULAR. POTENTIAL ADVERSE EFFECTS THAT MIGHT BE ASSOCIATED WITH THE CLARIVEIN DEVICE ARE SIMILAR TO THOSE ASSOCIATED WITH ANY INTERVENTIONAL VASCULAR PROCEDURE. THE DIRECTIONS FOR USE PROVIDED WITH THE CLARIVEIN DEVICE INSTRUCT THE USER TO CONSULT LABELING OF AGENTS TO BE DELIVERED PRIOR TO INFUSION. THE PHYSICIAN DELIVERED POLIDOCANOL TO THE RIGHT SSV. THE SPJ & SSV WERE REPORTED SUCCESSFULLY CLOSED WITHOUT COMPLICATIONS. IN A ROUTINE 5 DAY FOLLOW-UP, AN ACUTE, NON-OCCLUSIVE DVT WAS REPORTED IN THE RIGHT FEMORAL & PROXIMAL POPLITEAL VEIN (4 CM LONG WITH A 50% REDUCTION IN LUMEN DIAMETER POSSIBLY ATTACHED TO ANTERIOR WALL). PATIENT WAS REPORTED ALREADY ON PLAVIX AND WAS PRESCRIBED ELIQUIS. ULTRASOUND FOLLOW-UP IS SCHEDULED FOR (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43931 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC 65-018-E4S N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other