BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC KIT 106CM 40CM TZ

    MDR report key: 10482098 · Received September 2, 2020

    Report

    Report Number
    2134265-2020-12105
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 13, 2020
    Report Date
    October 27, 2020
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS NOT RETURNED BY THE CUSTOMER; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. AN INVESTIGATION WAS PERFORMED WITH THE AVAILABLE INFORMATION (PRODUCT CODE, BATCH NUMBER, CUSTOMER, AS APPLICABLE) AND EFFORTS WERE TAKEN TO ENABLE THE DETERMINATION OF A PROBABLE CAUSE. THE COMPLAINT INVESTIGATION CONCLUSION CODE IS: CAUSE NOT ESTABLISHED BECAUSE THE DEVICE AND EVENT LOG WERE NOT RETURNED. THE REP STATED THEY WERE NOT GIVEN ACCESS TO DOWNLOAD THE EVENT LOG BECAUSE THE LAB IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SECOND PROCEDURE WAS NEEDED TO REPLACE THE CATHETER. AN EKOS CATHETER WAS USED TO TREAT DEEP VEIN THROMBOSIS (DVT) IN THE LEG. A TEMPERATURE ALARM OCCURRED AND WAS ABLE TO BE RESOLVED THROUGH TROUBLESHOOTING. THE THERAPY RAN FOR ANOTHER 8 HOURS UNTIL THE CONTROL UNIT ALARMED AGAIN AND ULTRASOUND WAS DISCONTINUED. AT THIS TIME, LYTIC THERAPY CONTINUED VIA THE INFUSION PUMP. THE NEXT MORNING, PATIENT WAS BROUGHT TO THE CATH LAB FOR FOLLOW UP AND THE THROMBUS WAS FOUND TO STILL BE PRESENT. ANOTHER EKOS CATHETER WAS PLACED AND THERAPY RAN WITHOUT ISSUE FOR ANOTHER 24 HOUR PERIOD. ADDITIONAL INTERVENTION THAT WAS PREVIOUSLY PLANNED DUE TO THE PATIENTS CHRONIC DVT WAS PERFORMED THE FOLLOWING DAY. IT WAS REPORTED THE CASE WAS SUCCESSFUL WITH NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECOND PROCEDURE WAS NEEDED TO REPLACE THE CATHETER. AN EKOSONIC CATHETER WAS USED TO TREAT DEEP VEIN THROMBOSIS (DVT) IN THE LEG. A TEMPERATURE ALARM OCCURRED AND WAS ABLE TO BE RESOLVED THROUGH TROUBLESHOOTING. THE THERAPY RAN FOR ANOTHER 8 HOURS UNTIL THE CONTROL UNIT ALARMED AGAIN AND ULTRASOUND WAS DISCONTINUED. AT THIS TIME, LYTIC THERAPY CONTINUED VIA THE INFUSION PUMP. THE NEXT MORNING, PATIENT WAS BROUGHT TO THE CATH LAB FOR FOLLOW UP AND THE THROMBUS WAS FOUND TO STILL BE PRESENT. ANOTHER EKOS CATHETER WAS PLACED AND THERAPY RAN WITHOUT ISSUE FOR ANOTHER 24 HOUR PERIOD. ADDITIONAL INTERVENTION THAT WAS PREVIOUSLY PLANNED DUE TO THE PATIENTS CHRONIC DVT WAS PERFORMED THE FOLLOWING DAY. IT WAS REPORTED THE CASE WAS SUCCESSFUL WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945345 EKOSONIC KIT 106CM 40CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention