BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC ENDOVASCULAR SYSTEM

    MDR report key: 3692779 · Received March 17, 2014

    Report

    Report Number
    3001627457-2014-00006
    Event Type
    Injury
    Date Received
    March 17, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    EKOS CORP.
    Product Code
    KRA
    PMA / PMN Number
    K081467
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL ULTRASOUND CORE WIRE WAS RETURNED, INSPECTED AND POWERED ON, AND APPEARED VISUALLY AND ELECTRICALLY NORMAL. THE EKOSONIC CONTROL UNIT WAS ALSO RETURNED, INSPECTED, AND FOUND TO FALL AN ELECTRICAL TEST. THE SOFTWARE HANDLED THE ELECTRICAL ISSUE APPROPRIATELY BY NOT ALLOWING THE SYSTEM TO RUN. GIVEN THAT TWO ULTRASOUND WIRES WOULD NOT RUN ON THE CONTROL UNIT, AND CONFIRMATION OF THE FAILED ELECTRICAL TEST, THE LACK OF SYSTEM ULTRASOUND IS ATTRIBUTED TO THE CONTROL UNIT. F/U REVEALED BASELINE ANGIOGRAPHY DEMONSTRATED BRISK FLOW THROUGH THE SFV AND POPLITEAL, ALTHOUGH THROMBUS WAS PRESENT. THE PT ALSO HAD A PULMONARY EMBOLISM. THE HOSPITAL STAFF SAID THE PHYSICIAN TRIED MULTIPLE TIMES TO ACCESS THE POPLITEAL VEIN BEFORE SUCCESSFULLY SHEATH. THE STAFF COULD OFFER NO THEORIES WHY, IN THE PRESENCE OF GOOD OUTFLOW IN THE PT'S SFV AND POPLITEAL, THE PT WOULD HAVE DEVELOPED COMPARTMENT SYNDROME. THE EKOS CATHETER WAS USED AS A STANDARD DRUG INFUSION CATHETER. THE PT WAS REPORTED TO BE RESTING COMFORTABLY AFTER THE FASCIOTOMY, HOWEVER, IT IS NOT POSSIBLE TO RULE OUT THE LACK OF ULTRASOUND AS A POTENTIAL CONTRIBUTION TO THE COMPARTMENT SYNDROME.

    Description of Event or Problem · 1

    CUSTOMER PLACED DEVICE INTO THE POPLITEAL VEIN TO TREAT DEEP VEIN THROMBOSIS AND THE ULTRASOUND WOULD NOT START. THE EKOSONIC CONTROL UNIT DISPLAYED AN ALARM ICON. THE EKOS ULTRASOUND CORE WIRE WAS REMOVED FROM THE EKOS CATHETER AND REPLACED WITH A NEW ULTRASOUND CORE. THE EKOSONIC CONTROL UNIT ALARMED AGAIN IMMEDIATELY. THE CUSTOMER THEN USED THE DEVICE AS A STANDARD DRUG INFUSION CATHETER. SEVERAL HOURS LATER, THE PT DEVELOPED COMPARTMENT SYNDROME IN THE CALF, DISTAL TO THE TREATMENT AREA. AN EMERGENT FASCIOTOMY WAS PERFORMED TO RELIEVE PRESSURE IN THE CALF. THE PT WAS REPORTED TO BE TESTING COMFORTABLY AFTER THE FASCIOTOMY. VENOGRAPHY AT BASELINE DEMONSTRATED THROMBUS IN THE SUPERFICIAL FEMORAL VEIN AND POPLITEAL VEIN. HOWEVER, THE THROMBUS DID NOT APPEAR TO BE OCCLUSIVE AND BLOOD FLOW WAS EVIDENT ON THE VENOGRAMS. AT NO TIME DID THE PT EXHIBIT TOTAL VENOUS OCCLUSION OR PHLEGMASIA DOLENS, AN OCCLUSIVE CONDITION CONSISTENT WITH SUBSEQUENT COMPARTMENT SYNDROME. THE CAUSE FOR THE PT'S COMPARTMENT SYNDROME COULD NOT BE DETERMINED BY THE MEDICAL STAFF AT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156911 EKOSONIC ENDOVASCULAR SYSTEM CATHETER, CONTINUOUS FLUSH KRA EKOS CORP. 106CM/18CM 130819018-002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention