BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLARIVEIN INFUSTION CATHETER

    MDR report key: 2192690 · Received June 13, 2011

    Report

    Report Number
    3005831739-2011-00002
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 10, 2011
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 DESCRIBES MINIMAL RELATED SYMPTOMS. SHE WILL CONTINUE TO BE MONITORED. ADDITIONALLY, DVT IS A KNOWN SIDE EFFECT OF SURGICAL INTERVENTION IN THE PERIPHERAL VENOUS SYSTEM. ADDITIONAL LOT NUMBERS: 4015, 4018; EXP DATE: 03/2013-05/2013. DEVICE MFR DATE: 04/2011-05/2011.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CLARIVEIN DEVICE WAS USED DURING A VENOUS ABLATION PROCEDURE ON THE SMALL SAPHENOUS VEIN. DURING THE POST-PROCEDURE F/U ON (B)(6) 2011, THE PT MENTIONED SLIGHT DISCOMFORT IN THE AREA OF TREATMENT. USING DUPLEX ULTRASOUND, A SMALL DVT WAS NOTED AT THE JUNCTION OF THE POSTERIOR TIBIAL VEIN AND THE POPLITEAL VEIN. THE PT WAS PRESCRIBED LOVENOX AND COMPRESSION STOCKINGS, AND ADVISED TO WALK OFTEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other