BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 16075340 · Received December 29, 2022

    Report

    Report Number
    3004742232-2022-00323
    Event Type
    Injury
    Date Received
    December 29, 2022
    Date of Event
    November 25, 2022
    Report Date
    December 29, 2022
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DIAMONDBACK 360® PERIPHERAL ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL STATES THAT VESSEL PERFORATION IS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE SYSTEM. INVESTIGATION OF THE EVENT IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 90% STENOSED, MODERATELY TORTUOUS, 180-270 DEGREE CALCIFIED LESION IN THE LEFT CIRCUMFLEX ARTERY. FOLLOWING THREE LOW-SPEED TREATMENTS, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED. TWO TREATMENTS WERE PERFORMED FOLLOWED BY AN ELECTROCARDIOGRAM (ECG) THAT REVEALED AN ABNORMALITY. A PERFORATION WAS OBSERVED ON CINEANGIOGRAPHY IMAGING. BALLOON ANGIOPLASTY WAS PERFORMED FOR HEMOSTASIS. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2824860 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 405924

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention