BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 7114752 · Received December 13, 2017

    Report

    Report Number
    3005831739-2017-00014
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    October 30, 2017
    Report Date
    December 13, 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 CLARIVEIN DEVICE WAS USED TO DELIVER 1% POLIDOCANOL TO THE SMALL SAPHENOUS VEIN. THE CLARIVEIN DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. THERE WERE NO ISSUES CITED WITH DEVICE PERFORMANCE. POTENTIAL ADVERSE EFFECTS THAT MIGHT BE ASSOCIATED WITH THE CLARIVEIN® DEVICE ARE SIMILAR TO THOSE ASSOCIATED WITH ANY INTERVENTIONAL VASCULAR PROCEDURE. THE IFU PROVIDED WITH THE CLARIVEIN DEVICE LISTS THE POTENTIAL ADVERSE EVENTS THAT MIGHT BE ENCOUNTERED DURING A PERIPHERAL VASCULATURE INFUSION PROCEDURE AS WELL AS INSTRUCTS THE USER TO CONSULT LABELING OF AGENTS TO BE DELIVERED PRIOR TO INFUSION.

    Description of Event or Problem · 1

    DURING A ROUTINE FOLLOW-UP PATIENT PRESENTS EVIDENCE OF DVT AFTER INFUSION OF PHYSICIAN SPECIFIED AGENT INTO THE RIGHT SMALL SAPHENOUS VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892504 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention