BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW ENDURANCE CATHETER

    MDR report key: 8078103 · Received November 15, 2018

    Report

    Report Number
    MW5081359
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 14, 2018
    Manufacturer
    TELEFLEX, INC. / ARROW INTERNATIONAL, INC.
    Product Code
    FOZ
    UDI-DI
    10801902132908
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING THE PLACEMENT OF AN ARROW ENDURANCE PERIPHERAL CATHETER, IT WAS NOTED THAT THE CATHETER APPEARED TO HAVE BROKEN OFF INSIDE THE PATIENT. THE PHYSICIAN WAS NOTIFIED. X-RAY OF LEFT UPPER ARM DID NOT NOTE ANY FOREIGN BODIES. VEIN APPEARED TO HAVE PHLEBITIS, AND PHYSICIAN BELIEVED HE NOTED FRAGMENT ON ULTRASOUND. PATIENT TAKEN TO THE OPERATING ROOM FOR EXPLORATION AND INTERVASCULAR FOREIGN BODY REMOVAL. NO FOREIGN BODY FOUND. PATIENT CONTINUES TO BE TREATED FOR ADMITTING DIAGNOSIS OF INTERCEREBRAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912491 ARROW ENDURANCE CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ TELEFLEX, INC. / ARROW INTERNATIONAL, INC. IPN037859 14F18G0422 10801902132908

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other| R