BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRRAFLOW CATHETER

    MDR report key: 18085819 · Received November 7, 2023

    Report

    Report Number
    3013508628-2023-00009
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 16, 2023
    Report Date
    November 7, 2023
    Manufacturer
    IRRAS USA, INC.
    Product Code
    JXG
    PMA / PMN Number
    K231664
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CATHETER NOTED TO HAVE A TEAR AT THE PATIENT'S BEDSIDE BY THE CAREGIVERS AND COMPANY REPRESENTATIVE, WHICH WAS CONFIRMED UPON RECEIPT OF CATHETER BY MANUFACTURER FROM THE HOSPITAL. REFER TO ATTACHED INVESTIGATION REPORT WITH PHOTOS WHICH INDICATED THAT THE CATHETER WALL WAS BREACHED APPEARING TO HAVE OCCURRED SECONDARY TO CONTACT WITH A SHARP OBJECT WHILE STILL IN PATIENT USE.

    Description of Event or Problem · 0

    INTRAVENTRICULAR HEMORRHAGE PATIENT, 52 Y.O. MALE, AT (B)(6) HOSPITAL: IRRAFLOW CATHETER PLACEMENT AND TREATMENT INITIATED ON (B)(6) 2023 AT AROUND 22:00, AND ACTIVE FLUID EXCHANGE BEGAN. BOTH HOURLY OUTPUT AND ICPS WERE WITHIN DESIRED RANGE. AT 0400 ON (B)(6) 2023 TREATMENT WAS PAUSED AND PATIENT WAS TAKEN TO CT. UPON RETURN AND RESTART OF TREATMENT AFTER CT, ICPS WERE READING ZERO TO NEGATIVE AND AIR WAS VISIBLE IN THE VENTRICLES IN THE CT IMAGES. THE CAREGIVERS INCREASED IRRIGATION RATE TO 60MLS/HOUR FROM 30MLS/HOUR, AND RAISED THE DRAINAGE BAG IN AN ATTEMPT TO PUSH THE AIR OUT OF THE VENTRICLES. HOURLY OUTPUT REMAINED AS NET POSITIVE WITHIN DESIRED RANGE. ICPS CONTINUED TO READ BETWEEN -3 TO 2. ON (B)(6) 2023 AROUND 1900, AN ANESTHESIA RESIDENT NOTICED FLUID LEAKING FROM THE CATHETER AND IDENTIFIED A SMALL NICK IN THE CATHETER. THE IRRAFLOW CATHETER WAS REMOVED AND REPLACED IT WITH A STANDARED EVD. PATIENT'S CONDITIONED CONTINUED TO DECLINE THROUGHOUT THE DAY ON (B)(6) 2023, HOWEVER PATIENT DID NOT EXPIRE. IRRAS REPRESENTATIVE WHO FORWARDED THIS REPORT STATED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE AS OF 10/31/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339893 IRRAFLOW CATHETER EVD JXG IRRAS USA, INC. 2.0

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention