BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC KIT 135CM 50CM TZ

    MDR report key: 11717702 · Received April 23, 2021

    Report

    Report Number
    2134265-2021-05053
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 17, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K182324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3 - DEVICE EVALUATED BY MANUFACTURER: THE EKOS ULTRASONIC CORE (USC) WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THE DEVICE WAS INSPECTED FOR ANY DAMAGE OR IRREGULARITIES. THE USC SHOWED DAMAGE IN THE FORM OF A SEPARATION LOCATED 63.4 CM FROM THE HUB. BECAUSE OF THE SEPARATION FURTHER FUNCTIONAL TESTING COULD NOT BE COMPLETED. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE. DEVICE ANALYSIS DETERMINED THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE REPORTED INFORMATION OF A BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ULTRASONIC CORE BREAK OCCURRED. AN EKOSONIC CATHETER WAS BEING PLACED TO TREAT THE PATIENT'S THROMBOSED LOWER EXTREMITY BYPASS GRAFT. A CONTRALATERAL APPROACH WAS TAKEN WITH A GUIDING SHEATH GOING UP AND OVER. THE INFUSION CATHETER WAS PLACED, AND THEN THE ULTRASONIC CORE WAS ADVANCED AND RESISTANCE WAS MET. THE ULTRASONIC CORE KINKED AND THEN BROKE. THE ULTRASONIC CORE WAS COMPLETELY REMOVED FROM THE PATIENT WITHOUT COMPLICATION. A NEW EKOSONIC CATHETER WAS PREPARED AND AGAIN THE ULTRASONIC CORE WAS UNABLE TO ADVANCE AND KINKED. THE PROCEDURE WAS COMPLETED USING THE CATHETER AS A REGULAR INFUSION CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ULTRASONIC CORE BREAK OCCURRED. AN EKOSONIC CATHETER WAS BEING PLACED TO TREAT THE PATIENT'S THROMBOSED LOWER EXTREMITY BYPASS GRAFT. A CONTRALATERAL APPROACH WAS TAKEN WITH A GUIDING SHEATH GOING UP AND OVER. THE INFUSION CATHETER WAS PLACED, AND THEN THE ULTRASONIC CORE WAS ADVANCED AND RESISTANCE WAS MET. THE ULTRASONIC CORE KINKED AND THEN BROKE. THE ULTRASONIC CORE WAS COMPLETELY REMOVED FROM THE PATIENT WITHOUT COMPLICATION. A NEW EKOSONIC CATHETER WAS PREPARED AND AGAIN THE ULTRASONIC CORE WAS UNABLE TO ADVANCE AND KINKED. THE PROCEDURE WAS COMPLETED USING THE CATHETER AS A REGULAR INFUSION CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608992 EKOSONIC KIT 135CM 50CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-56150

    Patients

    Seq Age Sex Outcome Treatment
    1