BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11010767 · Received December 15, 2020

    Report

    Report Number
    3004742232-2020-00408
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 15, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005794
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE DEVICE FOR ANALYSIS IS ANTICIPATED. IF THE DEVICE IS RECEIVED FOR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT AN IN-STENT RESTENOSIS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). SIX TREATMENT PASSES WERE PERFORMED AT HIGH SPEED USING A FORWARD AND BACK TECHNIQUE. DURING TREATMENT, THE OAD BECAME STUCK WITHIN THE STENT. THE OAD WAS OPERATED AT HIGH SPEED IN AN ATTEMPT TO LOOSEN IT, HOWEVER THE OAD JUMPED FORWARD TO THE DISTAL LAD. THE OAD WAS PULLED FIRMLY, BUT COULD NOT BE REMOVED. THE SHEATH OF THE OAD WAS CUT AND AN ATTEMPT WAS MADE TO PULL THE OAD OUT WITH THE EXTENSION CATHETER, BUT THIS WAS UNSUCCESSFUL. INSERTION OF A BALLOON WAS ATTEMPTED, BUT ALSO FAILED TO REMOVE THE OAD. THE PATIENT WAS TRANSFERRED TO SURGERY AND THE DRIVESHAFT WAS REMOVED FROM THE PATIENT AND IT WAS CONFIRMED THAT THE STENT WAS WRAPPED AROUND IT. FOLLOWING REMOVAL OF THE OAD, A CABG PROCEDURE WAS PERFORMED AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480089 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 322412 10852528005794

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R