BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKOSONIC ENDOVASCULAR CATHETER

    MDR report key: 5238731 · Received November 17, 2015

    Report

    Report Number
    3001627457-2015-00008
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 20, 2015
    Report Date
    October 22, 2015
    Manufacturer
    EKOS CORP.
    Product Code
    KRA
    PMA / PMN Number
    K140151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    AN EKOS CORPORATION REPRESENTATIVE HAS ASKED FOR THE RETURN TO THE CATHETERS FOR EVALUATION, BUT THEY ARE CURRENTLY RETRAINED BY THE RISK MANAGEMENT DEPARTMENT IN THE HOSPITAL. SINCE THE PRODUCT WAS NOT RETURNED, FURTHER PRODUCT INVESTIGATION IS NOT POSSIBLE. THE HOSPITAL'S OPERATING ROOM REPORTED THEY USED THE DEVICE WITH A SHEATH THAT HAS A ROTATING HEMOSTASIS VALVE. COMPLAINANT WAS UNABLE TO PROVIDE FURTHER PATIENT/PRODUCT/PROCEDURAL DETAILS.

    Description of Event or Problem · 1

    ACCORDING TO THE TREATING PHYSICIAN: HE PLACED TWO EKOS CATHETERS IN THE PULMONARY ARTERIES OF A PATIENT WHO HAD A PE. AFTER TREATMENT THE CATHETERS WERE REMOVED IN THE ICU AND THE PATIENT WAS ALSO BROUGHT BACK INTO THE OPERATION ROOM FOR A PULMONARY ANGIOGRAM. ONE OF THE RADIOPAQUE MARKER BANDS HAD SEPARATED FROM ONE OF THE CATHETERS AND WAS SITTING IN THE PATIENT'S PULMONARY ARTERY. HE DID NOT SPECIFY WHICH ARTERY THIS WAS. HE TRIED BRIEFLY TO REMOVE THE BAND WITH ASPIRATION USING A MULTIPURPOSE CATHETER. THIS ATTEMPT WAS NOT SUCCESSFUL SO HE CEASED HIS EFFORTS AND LEFT THE MARKER BAND IN THE PATIENT. ON FOLLOW-UP THE NEXT MORNING, AN EKOS REPRESENTATIVE REPORTED THE PATIENT WAS STABLE WITH NO IMPROVING OR WORSENING SYMPTOMS SINCE THE INITIATION OF THE PROCEDURE. THE OPERATION ROOM DID SAVE BOTH CATHETERS AND SAID THEY WOULD RETURN THEM TO AN EKOS REPRESENTATIVE. THE OPERATION ROOM DID CONFIRM THAT THE SHEATH USED HAD A ROTATING HEMOSTASIS VALVE ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760995 EKOSONIC ENDOVASCULAR CATHETER CATHETER, CONTINUOUS FLUSH KRA EKOS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1