BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARIVEIN INFUSION CATHETER

    MDR report key: 1613190 · Received February 5, 2010

    Report

    Report Number
    3005831739-2010-00001
    Event Type
    Other
    Date Received
    February 5, 2010
    Date of Event
    January 8, 2010
    Report Date
    February 4, 2010
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. THE PHYSICIAN SAID THAT THE DEVICE DID NOT MALFUNCTION AND CONFIRMED THAT THE DEVICE WORKED PROPERLY DURING SURGERY. THE PT IS DOING WELL AND CONTINUES TO BE ASYMPTOMATIC. ADDITIONALLY, DVT IS A KNOWN SIDE AFFECT FOR THESE TYPES OF SURGICAL PROCEDURES. THIS IS THE FIRST REPORTED INCIDENT OF THIS TYPE RELATED TO THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A VENOUS ABLATION PROCEDURE ON THE SMALL SAPHENOUS VEIN. AT THE FIRST POST PROCEDURE FOLLOW UP, VENOUS DUPLEX ULTRASOUND EXAMINATION ((B)(6) 2010), A CLOT WAS OBSERVED IN THE RIGHT POPLITEAL VEIN. THE PT WAS ASYMPTOMATIC. THE PT WAS PRESCRIBED LOVENOX AND A COMPRESSION STOCKING. THERE WERE NO SERIOUS INJURIES AND THE LAST FOLLOW UP ON (B)(6) 2010 FOUND THE PT TO BE DOING WELL AND REMAINS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIVEIN INFUSION CATHETER INFUSION CATHETER KRA VASCULAR INSIGHTS LLC VC01-02-047-01 ME651405009J

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other