BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYMPHONY CATHETER

    MDR report key: 23986563 · Received January 6, 2026

    Report

    Report Number
    3014590708-2026-00001
    Event Type
    Death
    Date Received
    January 6, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 6, 2026
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    QEW
    UDI-DI
    00850032079129
    PMA / PMN Number
    K252057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SYMPHONY 24F DEVICE WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. THE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED THE PRODUCT MET DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, THE PHYSICIAN IDENTIFIED A HYPERCOAGULABLE STATE AS THE PRIMARY CONTRIBUTING FACTOR TO THE ADVERSE OUTCOME. THERE WAS NO MALFUNCTION OR DEVICE ISSUE NOTED WITH THE SYMPHONY 24F DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULMONARY EMBOLISM (PE) THROMBECTOMY PROCEDURE, THE PHYSICIAN NAVIGATED A PIGTAIL CATHETER TO MAIN PULMONARY ARTERY (PA) AND PERFORMED POWER INJECTION CONFIRMING THE CLOT LOCATION TO BE BILATERAL. THIRD PARTY DEVICES WERE USED AND SYMPHONY 24F WAS ADVANCED TO THE RIGHT PULMONARY ARTERY (PA). ONE PASS WAS PERFORMED WITH THE SYMPHONY 24F CATHETER WHICH RETRIEVED SIGNIFICANT CLOT. AT THIS POINT, THE PATIENT BEGAN COUGHING, HOWEVER NO HEMOPTYSIS WAS NOTED. THE SYMPHONY 24F WAS REPOSITIONED TO MAIN PULMONARY ARTERY (PA), AND THE PATIENT BEGAN TO DECOMPENSATE. THE PHYSICIAN REINSERTED THE DILATOR, ADVANCED THIRD-PARTY WIRE, AND USED SYMPHONY 24F TO THE OSTIUM OF LATERAL BRANCH. A PASS WAS PERFORMED HOWEVER NO CLOT WAS RETRIEVED. SYMPHONY 16F WAS THEN USED AND THE PATIENT CONTINUED TO DECOMPENSATE. CHEST COMPRESSIONS WERE INITIATED. THE PHYSICIAN THEN USED SYMPHONY 16F, BUT NO CLOT WAS RETRIEVED. THROMBECTOMY PROCEDURE WAS STOPPED, AND A CODE WAS CALLED. POWER INJECTION WAS PERFORMED WHILE THE STAFF CONTINUED WITH CHEST COMPRESSIONS. A LARGE CLOT WAS NOTED IN THE RIGHT PULMONARY ARTERY. THE PHYSICIAN USED SYMPHONY 24F TO THE RIGHT SIDE AS CHEST COMPRESSIONS CONTINUED. SLUGGISH FLOW WAS NOTED ON POWER INJECTION; HOWEVER, NO CLOT WAS REMOVED FROM THE SECOND PASS ON THE RIGHT. EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PREPARATION WAS STARTED BUT AFTER ~30 MINUTES OF RESUSCITATION, THE PATIENT HAD NO PUPILLARY RESPONSE AND WAS PRONOUNCED DECEASED. THE PHYSICIAN INDICATED THAT THE PATIENT'S CARDIAC ARREST AND SUBSEQUENT DEATH WERE NOT ATTRIBUTED TO THE SYMPHONY DEVICE OR THE THROMBECTOMY PROCEDURE. THE PATIENT HAD EXPERIENCED SYMPTOMS SIMILAR TO THOSE PRESENT AT THE TIME OF DECOMPENSATION PRIOR TO THE PROCEDURE. THE PHYSICIAN IDENTIFIED A HYPERCOAGULABLE STATE AS THE PRIMARY CONTRIBUTING FACTOR TO THE ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47552 SYMPHONY CATHETER SYMPHONY CATHETER QEW IMPERATIVE CARE INC. SYMPHONY24F V2527909 00850032079129

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Death 24F GORE DRYSEAL 33CM SHEATH| 6F SHEATH| AMPLATZ WIRE| GLIDEWIRE ADVANTAGE| MICROPUNCTURE KIT| PIGTAIL CATHETER| POWER INJECTION| SYMPHONY 16F| VERTEBRAL CATHETER