BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 7491268 · Received May 7, 2018

    Report

    Report Number
    3001627457-2018-00016
    Event Type
    Death
    Date Received
    May 7, 2018
    Date of Event
    April 10, 2018
    Report Date
    April 10, 2018
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION WAS REPORTED. PERFORATION OF THE VESSEL WITH THE EKOS CATHETER INTO THE AIRWAY IS CONSIDERED USE ERROR AND RESULTED IN SERIOUS INJURY AND DEATH. VESSEL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF THIS PROCEDURE LISTED IN THE INSTRUCTIONS FOR USE. IT SHOULD BE NOTED THAT THE INITIAL REPORTER WAS NOT THE PHYSICIAN THAT TREATED THIS PATIENT. FOLLOW UP WAS MADE WITH THE TREATING PHYSICIAN ON 16 APRIL 2018 AND LIMITED INFORMATION WAS RECEIVED AND HAS BEEN REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TWO EKOS DEVICES WERE USED TO TREAT A PATIENT WITH A BILATERAL PULMONARY EMBOLISM (PE). TREATMENT WAS REPORTED TO BE TPA 1 MG/HR BILATERAL FOR 4 HOURS. UPON REMOVAL OF THE EKOS CATHETER, THE PATIENT EXPERIENCED A MASSIVE HEMOPTYSIS. THE TREATING PHYSICIAN REPORTED THAT HE BELIEVES THAT THE EKOS CATHETER PERFORATED THROUGH THE WALL OF THE VESSEL AND INTO THE AIRWAY. AFTER REMOVAL OF THE DEVICE, BLOOD STARTED LEAKING INTO THE PATIENT'S AIRWAY. THE TREATING PHYSICIAN FELT THAT THE ELEVATED PULMONARY ARTERY (PA) PRESSURES WORSENED THE BLEEDING. THE PATIENT DIED SOON AFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332288 EKOSONIC ENDOVASCULAR CATHETER CATHETER KRA EKOS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death