BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN INFUSION CATHETER

    MDR report key: 1693983 · Received May 17, 2010

    Report

    Report Number
    3005831739-2010-00004
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    April 20, 2010
    Report Date
    May 10, 2010
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    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. NO DEVICE MALFUNCTION IS ASSOCIATED WITH THIS EVENT. THE PT SYMPTOMS OCCURRED AFTER A CLARIVEIN PROCEDURE, BUT THERE IS NO EVIDENCE OF DVT IN THE TREATED LEG. DOPPLER EXAM OF THE LEG POST PROCEDURE WAS NORMAL. THE CT SCAN OF THE LUNG SHOWS MULTIPLE SMALL PULMONARY EMBOLI IN THE LUNGS BUT NO FINDING IN THE TREATED LEG. THE CLOT COULD HAVE COME FROM THE CLARIVEIN PROCEDURE. HOWEVER, THE EVIDENCE IS NON SPECIFIC AND THE SOURCE OF THE PULMONARY EMBOLISM IS UNK.

    Description of Event or Problem · 1

    THE PT UNDERWENT A LEFT CLARIVEIN PROCEDURE ON (B) (6) 2010, (AASV AND GSV). THREE DAYS AFTER THE PROCEDURE ((B) (6) 2010), THE PT DEVELOPED SHORTNESS OF BREATH (SOB), LEFT-SIDED PAIN ON INSPIRATION, DIFFICULTY WITH WALKING DUE TO SOB, MARKED FATIGUE. ALSO REPORTS HAVING DISCOMFORT IN HER LEFT CHEST WHICH SHE DESCRIBES AS A SHARP PAIN WITH DISCOMFORT WITH DEEP INSPIRATION AND IS SHORT OF BREATH WHILE CLIMBING STAIRS. THE PT WAS SENT TO (B) (6) HOSPITAL ER WHERE SHE WAS EVALUATED FURTHER AND A CT OF THE LUNGS WAS PERFORMED. SHE WAS TREATED FOR PULMONARY EMBOLISM. THE PT PROGNOSIS IS GOOD. SHE WAS RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARIVEIN INFUSION CATHETER INFUSION CATHETER KRA VASCULAR INSIGHTS LLC VC01-01-047-01 ME451400310J

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O