BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARIVEIN IC INFUSION CATHETER

    MDR report key: 6593490 · Received May 26, 2017

    Report

    Report Number
    3005831739-2017-00003
    Event Type
    Injury
    Date Received
    May 26, 2017
    Report Date
    May 25, 2017
    Manufacturer
    VASCULAR INSIGHTS LLC
    Product Code
    KRA
    PMA / PMN Number
    K071468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE DID NOT MALFUNCTION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED POST PROCEDURE THE PHYSICIAN CHECKED THE VEIN UNDER ULTRASOUND AND NOTED CLOSURE WITH NO EXTENSION INTO THE SFJ. THE PATIENT HAS HAD ONE DVT PRIOR IN THE LOWER CALF AREA, NON-TREATMENT RELATED. THE PATIENT WAS PRESCRIBED XARELTO®.

    Description of Event or Problem · 1

    PHYSICIAN USED CLARIVEIN TO DELIVER POLIDOCANOL TO A PATIENT ABOUT A WEEK PRIOR TO THE REPORTED EVENT. POST PROCEDURE HE CHECKED THE VEIN UNDER ULTRASOUND AND NOTED CLOSURE WITH NO EXTENSION INTO THE SFJ. HE REPORTS UPON FOLLOW-UP WITH ULTRASOUND (THREE DAYS POST PROCEDURE) THE PATIENT PRESENTED WITH A THROMBUS THAT EXTENDED INTO THE SFJ. DR. (B)(6) INDICATED IT WAS OCCLUDING ABOUT 90% OF THE DIAMETER OF THE SFJ. THE DEVICE DID NOT MALFUNCTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376370 CLARIVEIN IC INFUSION CATHETER CLARIVEIN IC INFUSION CATHETER KRA VASCULAR INSIGHTS LLC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening