BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY CATHETER

    MDR report key: 23662071 · Received November 26, 2025

    Report

    Report Number
    3014590708-2025-00027
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 28, 2025
    Report Date
    November 26, 2025
    Manufacturer
    IMPERATIVE CARE INC.
    Product Code
    QEW
    UDI-DI
    00850032079211
    PMA / PMN Number
    K252057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. THE MANUFACTURING RECORDS WERE REVIEWED AND DEMONSTRATED THAT THE PRODUCT MET THE DESIGN AND MANUFACTURING SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, THERE WAS NO MALFUNCTION REPORTED DURING THE CASE. IT IS UNKNOWN IF THE DISSECTION WAS CAUSED DUE TO THIRD PARTY DEVICES OR THE SYMPHONY 16F 82CM CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, ACCESS WAS OBTAINED VIA A THIRD-PARTY MICROPUNCTURE DEVICE, 16F SHEATH AND GUIDEWIRE IN THE LEFT POPLITEAL VEIN. THE WIRE WAS ADVANCED WITH ASSISTANCE OF A THIRD-PARTY DIAGNOSTIC CATHETER, FOLLOWED BY USE OF SYMPHONY 16F 82CM CATHETER OVER THE GUIDEWIRE. THE SYMPHONY 16F 82CM CATHETER SUCCESSFULLY CROSSED FROM THE ILIAC TO THE INFERIOR VENA CAVA (IVC) AND ASPIRATION WAS PERFORMED SUCCESSFULLY. A RESIDUAL VENOGRAM REVEALED CALCIFICATION. THE PHYSICIAN DEPLOYED A THIRD-PARTY BALLOON AND SUBSEQUENT VENOGRAM REVEALED A NON-FLOW LIMITING DISSECTION IN THE FEMORAL VEIN. INTRAVASCULAR ULTRASOUND (IVUS) WAS THEN UTILIZED FOR MEASUREMENTS AND IDENTIFYING RESIDUAL CLOTS. A SECOND PASS WAS THEN PERFORMED WITH SYMPHONY 16F 82CM CATHETER BEFORE PLACEMENT OF STENT AND POST-DILATION. VENOGRAPHY SHOWED TWO RESIDUAL CHRONIC PLAQUES, AND A THIRD PASS WITH SYMPHONY 16F 82CM CATHETER CLEARED THE CHRONIC CLOT FROM THE COMMON FEMORAL VEIN. THE CAUSE OF THE DISSECTION IS UNKNOWN AND COULD BE ASSOCIATED WITH THE THIRD-PARTY WIRE, SYMPHONY 16F 82CM CATHETER, OR THIRD-PARTY BALLOON. PER THE PHYSICIAN, LIKELY THE BALLOON ANGIOPLASTY LED TO THE DISSECTION. THERE WAS NO DEVICE ISSUE OR MALFUNCTION REPORTED WITH THE SYMPHONY 16F 82CM DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783154 SYMPHONY CATHETER SYMPHONY CATHETER QEW IMPERATIVE CARE INC. SYMPHONY16F82 F2519201 00850032079211

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown Required Intervention 2 ATLAS BALLOON.| ABRE VENOUS STENT.| BERENSTEIN CATHETER.| COOK SHEATH.| GLIDE ADVANTAGE WIRE.| IVUS CATHETER.| MICROPUNCTURE DEVICE.