BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER, CONTINUOUS FLUSH

    MDR report key: 10473457 · Received August 31, 2020

    Report

    Report Number
    2134265-2020-11818
    Event Type
    Injury
    Date Received
    August 31, 2020
    Date of Event
    March 1, 2020
    Report Date
    August 31, 2020
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LICHTENBERG, MICHAEL K. W., ET AL. ENDOVASCULAR MECHANICAL THROMBECTOMY VERSUS THROMBOLYSIS IN PATIENTS WITH ILIOFEMORAL DEEP VEIN THROMBOSIS, A SYSTEMATIC REVIEW AND META ANALYSIS. VASA, 2020, PP. 1:9., DOI:10.1024/0301-1526/A000875. DATE OF EVENT WAS APPROXIMATED BASED ON SUBMISSION DATE OF ARTICLE.

    Description of Event or Problem · 1

    PER LITERATURE ARTICLE "ENDOVASCULAR MECHANICAL THROMBECTOMY VERSUS THROMBOLYSIS IN PATIENTS WITH ILIOFEMORAL DEEP VEIN THROMBOSIS, A SYSTEMATIC REVIEW AND META ANALYSIS" IT WAS REPORTED THAT MAJOR BLEEDING AND POST-THROMBOTIC SYNDROME OCCURRED POST ULTRASOUND ASSISTED CATHETER DIRECTED THROMBOLYSIS (UA CDT). A META-ANALYSIS WAS PERFORMED TO COMPARE EFFECTIVENESS AND SAFETY OF PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) AND THROMBOLYSIS ALONE (THR) IN PATIENTS WITH ACUTE OR SUBACUTE ILIOFEMORAL DEEP VEIN THROMBOSIS (IFDVT). ULTRASOUND ASSISTED CATHETER DIRECTED THROMBOLYSIS (UA CDT) WAS REFERENCED WITHIN THE STUDY. FOUR MAJOR BLEEDING INCIDENTS AFTER ILIOFEMORAL DEEP VEIN THROMBOSIS WITH UA CDT WERE NOTED TO HAVE OCCURRED. PAIN AND SWELLING ARE ASSOCIATED WITH POST-THROMBOTIC SYNDROME. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936623 CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other