BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 6930207 · Received October 9, 2017

    Report

    Report Number
    3001627457-2017-00030
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 8, 2017
    Report Date
    September 8, 2017
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006301
    PMA / PMN Number
    K140151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED TO EKOS FOR EVALUATION ON 9/27/17. VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED CRAZING AND CRACKING IN THE MANIFOLD LURE. A COLORED FLUID WAS INJECTED THROUGH THE LURE LOCK AND LEAKING WAS OBSERVED FROM THE LURE CONFIRMING THE REPORTED ISSUE. OUR REVIEW OF MANUFACTURING RECORDS INDICATES THAT PRODUCT WAS MANUFACTURED ACCORDING TO OUR SPECIFICATION AND MET ALL RELEASE CRITERIA. DURING OUR INVESTIGATION WE FOUND THE THREE-WAY STOP COCKS TO BE VERY TIGHTLY ATTACHED TO THE LURES. WE ADVISED THE CUSTOMER THAT CARE SHOULD BE TAKEN WHEN CONNECTING THE LURE LOCKS TO SECURELY CONNECT THE LURES WHILE AVOIDING OVERTIGHTING. WE ARE FILLING THIS MDR IN RESPONSE TO THE USER FACILITY'S MEDWATCH REPORT #(B)(4) THAT WE RECEIVED FROM THE (B)(4) ON 9/11/2017. ACCORDING TO THE USER FACILITY'S MEDWATCH, A NEW DEVICE WAS REPLACED IN THE PATIENT AND CARE OF THE PATIENT WAS NOT COMPROMISED. THE ORIGINAL PLAN TO USE EKOS OVERNIGHT WAS RESUMED. THERE WAS NO REPORT FROM THE USER OF AN ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    A 135CM/40CM EKOSONIC CATHETER, S/N (B)(4), WAS USED TO TREAT A PATIENT ON (B)(6) 2017. THE PHYSICIAN SUCCESSFULLY PLACED THE INFUSION CATHETER (IDDC, PART OF THE EKOSONIC CATHETER) IN THE PATIENT AND SUBSEQUENTLY PLACED ULTRASOUND CORE (MSD, MICROSONIC DEVICE) INSIDE THE IDDC. IT WAS REPORTED TO EKOS THAT FLUID WAS LEAKING FROM THE CATHETER. THEY DESCRIBED THE MANIFOLD SECTION (WHERE THE MSD AND IV FLUIDS MEET) OF CATHETER AS THE SOURCE OF THE LEAK. THE NURSE NOTIFIED THE PHYSICIAN THE CATHETER WOULD NEED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711971 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION 00858593006301

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR