BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 17656508 · Received August 30, 2023

    Report

    Report Number
    3004742232-2023-00226
    Event Type
    Injury
    Date Received
    August 30, 2023
    Report Date
    August 30, 2023
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED OADS COULD NOT BE REVIEWED AS THE LOT NUMBERS WERE NOT PROVIDED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. H6 INVESTIGATION CONCLUSION CODE 22: THE DIAMONDBACK 360® CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USER MANUAL STATES THAT A VASCULAR DISSECTION, BLEEDING, HEART FAILURE, CARDIOGENIC SHOCK, AND A PERFORATION OF VESSELS ARE A POTENTIAL ADVERSE EVENT THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE SYSTEM. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A LITERATURE REVIEW FROM THE CARDIOVASCULAR REVASCULARIZATION MEDICINE BY GHAZZAL ET AL. "ORBITAL ATHERECTOMY SAFETY AND EFFICACY: A COMPARATIVE ANALYSIS OF OSTIAL VERSUS NON-OSTIAL CALCIFIED CORONARY LESIONS" OBSERVED THREE TYPE 2 BLEEDING EVENTS, NINE TYPE 1 BLEEDING EVENTS, THREE MAJOR DISSECTIONS, FIVE PERFORATIONS, FIVE CARDIOGENIC SHOCK EVENTS, AND THREE HEART FAILURE EVENTS. AMRE GHAZZAL, BRAD J. MARTINSEN, SELIN SENDIL, CHRISTIAN A. TORRES, GARLY SAINT CROIX, PRINCE SETHI, RALPH CIPRIANO, AJAY J. KIRTANE, MARTIN B. LEON, NIRAT BEOHAR. ORBITAL ATHERECTOMY SAFETY AND EFFICACY: A COMPARATIVE ANALYSIS OF OSTIAL VERSUS NON-OSTIAL CALCIFIED CORONARY LESIONS. CARDIOVASCULAR REVASCULARIZATION MEDICINE. 2023. ISSN 1553-8389. HTTPS://DOI.ORG/10.1016/J.CARREV.2023.07.013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263436 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other