BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC KIT 135CM 50CM TZ

    MDR report key: 10905915 · Received November 25, 2020

    Report

    Report Number
    2134265-2020-16457
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 4, 2020
    Report Date
    January 21, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K182324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER CAME BACK FOR ANALYSIS. NO DAMAGE WAS OBSERVED ON THE DRUG LUER, THE COOLANT LUER, OR THE MANIFOLD LUER. A KINK MARK WAS OBSERVED 83.0 CM DISTAL TO THE STRAIN RELIEF AND ANOTHER KINK WAS NOTED UNDER THE STRAIN RELIEF. FLUID WAS NOT SEEN EMITTING FROM THE LUERS WHEN EITHER THE DRUG AND COOLANT LINES WERE FLUSHED. FURTHER, NO BUBBLES WERE SEEN WHEN THE DEVICE WAS FLUSHED UNDER WATER. NO DAMAGE OR ISSUES WERE NOTED WITH THE ULTRASOUND CORE (USC). A POTENTIAL SOURCE OF THE LEAK COULD HAVE BEEN A MAL-FITTED CONNECTION TO THE DRUG LUER DURING THERAPY. AGE AT TIME OF EVENT: OVER 18 YEARS OF AGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LEAK OCCURRED FROM THE INTELLIGENT DRUG DELIVERY CATHETER (IDDC) PORT REQUIRING ADDITIONAL PROCEDURE FOR REPLACEMENT. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A DEEP VEIN THROMBOSIS (DVT) PROCEDURE. AT APPROXIMATELY 1-2 HOUR OF THERAPY RUN TIME, A LEAK WAS NOTED ON THE DRUG LUMEN. AT THIS TIME, ULTRASOUND WAS PAUSED. TROUBLESHOOTING STEPS TAKEN AND DID NOT RESOLVE THE LEAK. THE PATIENT WAS TAKEN BACK TO THE CATH LAB AND A NEW EKOS CATHETER WAS PLACED. THE THERAPY WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: OVER 18 YEARS OF AGE. THE REPORTED BATCH/LOT (200218011-004).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAK OCCURRED FROM THE INTELLIGENT DRUG DELIVERY CATHETER (IDDC) PORT REQUIRING ADDITIONAL PROCEDURE FOR REPLACEMENT. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A DEEP VEIN THROMBOSIS (DVT) PROCEDURE. AT APPROXIMATELY 1-2 HOUR OF THERAPY RUN TIME, A LEAK WAS NOTED ON THE DRUG LUMEN. AT THIS TIME, ULTRASOUND WAS PAUSED. TROUBLESHOOTING STEPS TAKEN AND DID NOT RESOLVE THE LEAK. THE PATIENT WAS TAKEN BACK TO THE CATH LAB AND A NEW EKOS CATHETER WAS PLACED. THE THERAPY WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369966 EKOSONIC KIT 135CM 50CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-56150 200218011-004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention