BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYMPHONY CATHETER

    MDR report key: 20741649 · Received November 20, 2024

    Report

    Report Number
    3014590708-2024-00039
    Event Type
    Death
    Date Received
    November 20, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 20, 2024
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    QEW
    UDI-DI
    00850032079112
    PMA / PMN Number
    K223216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AFTER USE AND THEREFORE NOT AVAILABLE FOR RETURN AND INVESTIGATION. NO DEVICE DEFICIENCIES WERE REPORTED RELATED TO THE SYMPHONY CATHETER. THE MANUFACTURING RECORDS FOR THE SYMPHONY DEVICE WAS REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET ALL THE DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON CASE IMAGES AND INFORMATION PROVIDED IT IS UNCLEAR IF THE PATIENT DEATH FROM PULMONARY EMBOLISM WAS CAUSED BY THE PATIENT'S PRE-EXISTING COMORBIDITIES, CONTRAST INJECTION, OR USE OF THE SYMPHONY CATHETER.

    Description of Event or Problem · 0

    ON THE EVENING OF (B)(6) 2024, A 77-YEAR-OLD-MALE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED. THE CT SCAN SHOWED THAT THE PATIENT'S RIGHT VENTRICLE/ LEFT VENTRICLE (RV/LV) RATIO WAS A 1.4. THE HOSPITAL'S ON-CALL INTERVENTIONAL RADIOLOGIST WAS CONSULTED REGARDING THE CT SCAN RESULTS. CT SCAN SHOWED THE ENTIRE RIGHT LUNG WAS OCCLUDED PROXIMAL TO THE TRUNCUS ANTERIOR. THE PATIENT'S LEFT LEG WAS NOTED TO BE SWOLLEN, SO AT AN UNSPECIFIED DATE AND TIME A DOPPLER ULTRASOUND WAS PERFORMED. ON THE MORNING OF (B)(6), AN ECHOCARDIOGRAM WAS PERFORMED. THE PATIENT WAS TRANSFERRED FOR A VENOUS THROMBECTOMY PROCEDURE. PRIOR TO PLACING A GORE 16F SHEATH, THE PHYSICIANS PERFORMED SEVERAL PRE-RUNS AND FOUND THE ILIAC WAS CLEAR WITH NO THROMBUS PRESENT. THROMBUS WAS NOTED FROM THE FEMORAL TO COMMON FEMORAL. THE PATIENT WAS POSITIONED IN A PRONE POSITION FOR A LEFT POPLITEAL ACCESS TO REMOVE A THROMBUS. A 16F SYMPHONY CATHETER WAS POSITIONED THROUGH A GORE 16F SHEATH, AND ASPIRATION STARTED. AFTER THE FIRST PASS IT WAS NOTED THAT CLOT WAS IN THE CATHETER. THERE WAS APPROXIMATELY A 50CC OF BLOOD LOSS. THE ACTIVATED CLOTTING TIME (ACT) WAS 140. THE PATIENT WAS ADMINISTERED 5000 UNITS OF HEPARIN. FOR THE SECOND PASS, THE SAME SYMPHONY CATHETER WAS REPOSITIONED, AND ASPIRATION WAS APPLIED. AN ADDITIONAL 50CC OF BLOOD LOSS WAS OBSERVED. CONTRAST WAS APPLIED THROUGH THE SYMPHONY AND A MAGNIFIED IMAGING (STARTING AT THE MID-FEMORAL) SHOWED NO SIGNS OF OCCLUSION. HOWEVER, AN EXPANDED IMAGING SHOWED AN APPARENT CLOT BEYOND THE MID-FEMORAL VEIN NEAR THE ILIAC. THE SYMPHONY WAS ADVANCED CLOSER TO THE SITE OF THE POTENTIAL CLOT. A SECOND CONTRAST WAS INJECTED THROUGH THE SYMPHONY. IMAGING SHOWED THAT THE AREA WHERE THE APPARENT CLOT HAD BEEN LOCATED WAS CLEAR. THE DEVICES WERE THEN REMOVED FROM THE PATIENT. WHILE CLOSING THE ACCESS SITE, THE PHYSICIAN NOTED A CHANGE IN THE PATIENT'S HEMODYNAMICS. APPROXIMATELY 3-5 MINUTES LATER A CODE BLUE WAS CALLED. THE PATIENT EXPIRED SOON AFTER. THE PHYSICIAN RUNNING THE CODE DECLARED THE CAUSE DEATH WAS DUE TO A MASSIVE PULMONARY EMBOLISM. NO DEVICE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2457818 SYMPHONY CATHETER THROMBECTOMY SUCTION CATHETER QEW IMPERATIVE CARE INC. SYMPHONY16F M1076032024 00850032079112

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Life Threatening GORE 16F SHEATH