BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7123544 · Received December 15, 2017

    Report

    Report Number
    3001627457-2017-00034
    Event Type
    Injury
    Date Received
    December 15, 2017
    Date of Event
    November 20, 2017
    Report Date
    November 20, 2017
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS REPORTED. THE PATIENT WAS SENT TO THE CICU WITH THE COOLANT RUNNING THROUGH THE COOLANT LUMEN BUT THE DRUG LINE WAS NOT FLOWING DUE TO A DELAY IN GETTING THE TPA FROM THE PHARMACY TO THE LAB. THE IFU INSTRUCTS THE USER TO PRIME THE DRUG LUMEN AND COMPLETE THE INFUSION PROCEDURE PRIOR TO MOVING THE PATIENT TO THE APPROPRIATE CARE UNIT OF THE HOSPITAL. THE USER ERROR OF NOT INFUSING ANY PHYSICIAN-SPECIFIED FLUIDS THROUGH THE DRUG LUMEN LIKELY CAUSED AN OCCLUSION. THE IFU INSTRUCTS THE USER THAT IF FLOW THROUGH THE INFUSION CATHETER BECOMES RESTRICTED, EITHER REMOVE THE INFUSION CATHETER (AND ULTRASONIC CORE, IF IN PLACE) TO DETERMINE AND ELIMINATE THE CAUSE OF THE OBSTRUCTION OR REPLACE THE INFUSION CATHETER WITH A NEW INFUSION CATHETER OF THE SAME MODEL. TROUBLESHOOTING THE OCCLUSION WAS UNSUCCESSFUL AND THE PATIENT WAS RETURNED TO THE CATH LAB FOR RE-INSERTION OF A NEW EKOS CATHETER. THE REQUIRED MEDICAL INTERVENTION INCLUDING ADDITIONAL EXPOSURE TO X-RAY AND A NEW CATHETER PLACEMENT WAS DUE TO USER ERROR AND NOT A RESULT OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2017 THROUGH A HELPLINE CALL THAT THE USER WAS HAVING ISSUES FLUSHING THE DRUG PORT OF A 50 CM EKOS CATHETER PLACED FOR A (B)(6) CASE. IT WAS REPORTED THAT THERE WAS A DELAY WITH THE PHARMACY GETTING THE TPA UP TO THE LAB, THEREFORE THE PATIENT WAS SENT TO THE CICU WITH COOLANT RUNNING THROUGH THE DEVICE BUT THE TPA LINE WAS NOT FLOWING YET AND THE ULTRASOUND WAS NOT TURNED ON. THE CALLER CONFIRMED THAT THEY FOLLOWED THEIR HOSPITAL PROTOCOL OF FLUSHING FORWARD, BUT THEIR ATTEMPTS WERE UNSUCCESSFUL. THE PHYSICIAN AGREED THAT THE PATIENT HAD TO GO BACK TO THE CATH LAB FOR RE-INSERTION OF A NEW EKOS CATHETER. FOLLOW UP WAS RECEIVED REPORTING THAT THE SECOND INSERTION OF AN EKOS 50CM CATHETER WAS SUCCESSFUL. THERAPY COMMENCED AND NO ADVERSE EVENTS WERE REPORTED IN ASSOCIATION WITH THE EKOS THERAPY. THE FIRST CATHETER WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE PHYSICIAN ACKNOWLEDGED THAT THIS EVENT WAS DUE TO USER ERROR AND NO DEVICE FAILURE WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900835 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention