BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 9989392 · Received April 23, 2020

    Report

    Report Number
    3001627457-2020-00012
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    March 6, 2020
    Report Date
    April 13, 2020
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    UDI-DI
    00858593006189
    PMA / PMN Number
    K182324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THAT THE RF WIRES HAD SHORTED INSIDE OF THE MSD HUB. A VOID WAS OBSERVED IN THE LOCTITE CONNECTING THE STRAIN RELIEF TO THE WHITE PORTION OF THE MSD LUER LOCK, WHICH LIKELY CONTRIBUTED TO FLUID INGRESS INTO THE HUB. IT WAS REPORTED THAT THE MSD WAS REPLACED, AND NO ADVERSE PATIENT OUTCOME HAS BEEN REPORTED. THE DEVICE SHORT WAS NOT REPORTED BY THE USER. NO DEFINITIVE ROOT CAUSE COULD BE IDENTIFIED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE PRODUCT WAS MANUFACTURED PER STANDARD PROCESSES AND MET ALL ACCEPTANCE CRITERIA. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FROM MSDS OF THE SAME LOT. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MICROSONIC DEVICE (MSD) CATHETER WOULD NOT RUN ANY LONGER THAN ONE MINUTE DURING A DVT CASE. NO FLUID INGRESS OR BENT PINS WAS FOUND BY THE CUSTOMER DURING TROUBLESHOOTING. THE CONTROL UNIT (CU) AND CONNECTOR INTERFACE CABLE (CIC) WAS EXCHANGED DURING TROUBLESHOOTING, BUT THE ISSUE DID NOT RESOLVE. THE MSD WAS REMOVED AND REPLACED WITH A NEW ONE. NO ISSUES WERE ENCOUNTERED AFTER EXCHANGING THE MSD. THE PATIENT WAS REPORTED TO BE DOING FINE. ON 13 APRIL 2020 A SHORT WAS NOTED IN THE HUB OF THE MSD DURING INVESTIGATION OF THE RETURNED DEVICE. THIS WAS NOT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454643 EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER KRA EKOS CORPORATION 500-55150 00858593006189

    Patients

    Seq Age Sex Outcome Treatment
    1