BEUDAMED
    FDA Adverse Event Death Summary report: N

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    MDR report key: 16294398 · Received February 3, 2023

    Report

    Report Number
    2124215-2023-03671
    Event Type
    Death
    Date Received
    February 3, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET 510(K) # K183361; K182324.

    Additional Manufacturer Narrative · 0

    PREMARKET 510(K) # K183361; K182324.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRACEREBRAL BRAIN HEMORRHAGE (ICH) AND WAS TRANSFERRED TO ANOTHER FACILITY FOR A HIGHER LEVEL OF CARE. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH TWO EKOS DEVICES. AN EKOSONIC ENDOVASCULAR DEVICE, 135X12CM (16103547) AND AN EKOSONIC ENDOVASCULAR DEVICE, 106X18CM (16108301) WERE SELECTED FOR USE. TREATMENT WAS COMPLETED WITH NO DEVICE ISSUES REPORTED. THE EKOS DEVICES WERE DISCARDED FOLLOWING TREATMENT. ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ICH AND WAS TRANSFERRED TO ANOTHER FACILITY FOR A HIGHER LEVEL OF CARE. IT WAS UNKNOWN WHETHER THE DEVICES OR PROCEDURE CONTRIBUTED TO THE ICH. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT PRIOR TO THE INDEX PROCEDURE ON (B)(6) 2023, THE PATIENT WAS ADMITTED FOR SHORTNESS OF BREATH. A CT SCAN WAS PERFORMED TO SEARCH FOR PULMONARY EMBOLISM, AND ECHOCARDIOGRAPHY CONFIRMED A DILATED RIGHT VENTRICLE. EKOS TREATMENT WAS PERFORMED FOR 6 HOURS. FOLLOWING COMPLETION OF THE EKOS TREATMENT, UPON DEVICE REMOVAL, THE PATIENT COMPLAINED OF RIGHT PERIPHERAL VISION LOSS. FOLLOWING THE TRANSFER TO ANOTHER FACILITY, THE PATIENT WAS TREATED WITH A NICARDIPINE DRIP AND 1G OF TRANEXAMIC ACID. A CT SCAN WAS REPEATED ON ARRIVAL AND THE BLEED APPEARED TO REMAIN STABLE AT THE TIME. AN IVC FILTER WAS PLACED TO TREAT THE PATIENT'S DEEP VEIN THROMBOSIS. THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INTRACEREBRAL BRAIN HEMORRHAGE (ICH) AND WAS TRANSFERRED TO ANOTHER FACILITY FOR A HIGHER LEVEL OF CARE. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH TWO EKOS DEVICES. AN EKOSONIC ENDOVASCULAR DEVICE, 135X12CM AND AN EKOSONIC ENDOVASCULAR DEVICE, 106X18CM WERE SELECTED FOR USE. TREATMENT WAS COMPLETED WITH NO DEVICE ISSUES REPORTED. THE EKOS DEVICES WERE DISCARDED FOLLOWING TREATMENT. ON (B)(6) 2023, THE PATIENT EXPERIENCED AN ICH AND WAS TRANSFERRED TO ANOTHER FACILITY FOR A HIGHER LEVEL OF CARE. IT WAS UNKNOWN WHETHER THE DEVICES OR PROCEDURE CONTRIBUTED TO THE ICH. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855789 EKOSONIC ENDOVASCULAR DEVICE, 106X18CM CATHETER, CONTINUOUS FLUSH KRA BOSTON SCIENTIFIC CORPORATION 500-55118

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| D| L EKOSONIC ENDOVASCULAR DEVICE, 135X12CM| EKOSONIC ENDOVASCULAR DEVICE, 135X12CM