BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARIVEIN INFUSION CATHETER

    MDR report key: 1993498 · Received February 8, 2011

    Report

    Report Number
    3005831739-2011-00001
    Event Type
    Other
    Date Received
    February 8, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 6, 2011
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. THE DEVICE DID NOT MALFUNCTION AND THE DEVICE WORKED PROPERLY DURING SURGERY. THE PT IS DOING WELL AND CONTINUES TO BE ASYMPTOMATIC. ADDITIONALLY, DVT IS A KNOWN SIDE AFFECT FOR SURGICAL PROCEDURES IN THE PERIPHERAL VENOUS SYSTEM.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE DEVICE WAS USED DURING A VENOUS ABLATION PROCEDURE ON THE GREAT SAPHENOUS VEIN. AT THE FIRST POST PROCEDURE F/U, VENOUS DUPLEX ULTRASOUND EXAMINATION ((B)(6) 2011), SHOWED DVT INVOLVING CFV ARIXTRA STARTED. THE PT WAS ASYMPTOMATIC. THE PT WAS PRESCRIBED COUMADIN AND A COMPRESSION STOCKING ((B)(6) 2011). F/U ULTRASOUND SCHEDULED IN ONE MONTH.

    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 ME65140461OI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other