BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11633305 · Received April 8, 2021

    Report

    Report Number
    3004742232-2021-00115
    Event Type
    Death
    Date Received
    April 8, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 8, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD FOR THE REPORTED OAD COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. IF THE LOT NUMBER IS PROVIDED, A DHR REVIEW WILL BE PERFORMED. CSI ID: (B)(4).

    Description of Event or Problem · 1

    ORBITAL ATHERECTOMY (OA) WAS SELECTED FOR TREATMENT OF THE LEFT MAIN (LM) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. A BALLOON WAS USED PRIOR TO OA TO ADVANCE THE GUIDE CATHETER THROUGH THE VESSEL AND THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON BOTH LOW AND HIGH SPEED IN THE LM AND LAD. THE PATIENT COMPLAINED OF CHEST PAIN AND THE OAD WAS REMOVED. THE PATIENT DECOMPENSATED WITHIN MINUTES AND CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED. FOLLOWING 20 MINUTES OF RESUSCITATION, A VESSEL PERFORATION WAS IDENTIFIED. STENTS WERE DEPLOYED, HOWEVER THE PERFORATION WAS UNABLE TO BE CONTAINED. AFTER 2.5 HOURS, THE CODE WAS CALLED, AND THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF THE PATIENT'S DEATH WAS UNCONTROLLABLE BLEEDING FROM THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532710 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death