BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 22469700 · Received July 10, 2025

    Report

    Report Number
    3004742232-2025-00198
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 13, 2025
    Report Date
    October 17, 2025
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    UDI-DI
    10850000491554
    PMA / PMN Number
    P130005
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE, STALL AND SHAFT FRACTURE APPEARS TO BE RELATED TO USER ERROR. IT WAS REPORTED THAT THE OAD WAS BEING RE-USED FOR A PROCEDURE TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE OAD WAS USED ON A DIFFERENT PATIENT PRIOR TO THIS PROCEDURE. IT SHOULD BE NOTED THAT THE DIAMONDBACK 360¿ CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE (IFU) 92-10023-01 REVISION F, WARNS: "DO NOT RE-STERILIZE OR RE-USE THE OAD. IF THE OAD IS RE-STERILIZED OR RE-USED, THE OAD MAY NOT FUNCTION PROPERLY POTENTIALLY LEADING TO SERIOUS INFECTION AND PATIENT HARM AND/OR DEATH.". BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. UPDATED: B5, H6 (CODES 4118, 3233, AND 11 NO LONGER APPLY).

    Additional Manufacturer Narrative · 0

    CORRECTION: G1.

    Description of Event or Problem · 0

    IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING RE-USED FOR A PROCEDURE TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE OAD WAS USED ON A DIFFERENT PATIENT PRIOR TO THIS PROCEDURE. IT WAS INDICATED THE RCA WAS DIFFICULT TO CROSS WITH THE OAD, WITH A NON-ABBOTT GUIDE CATHETER USED IN AN ATTEMPT TO CROSS, HOWEVER, THE OAD WAS NOT CROSSING. THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON AND THE OAD WAS ABLE TO CROSS. FOUR LOW SPEED TREATMENTS AND THREE HIGH SPEED TREATMENTS WERE PERFORMED. SUDDENLY, THE OAD STOPPED SPINNING AND STALLED. THE OAD WAS UNABLE TO BE POWERED BACK ON, EVEN IN GLIDEASSIST MODE. LATER, IT WAS OBSERVED THE OAD CROWN WAS DETACHED IN THE DISTAL RCA. ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED COMPONENT; HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT WAS SENT FOR SURGERY TO SUCCESSFULLY REMOVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING RE-USED FOR A PROCEDURE TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE OAD WAS USED ON A DIFFERENT PATIENT PRIOR TO THIS PROCEDURE. IT WAS INDICATED THE RCA WAS DIFFICULT TO CROSS WITH THE OAD, WITH A GUIDELINER USED IN AN ATTEMPT TO CROSS, HOWEVER, THE OAD STILL WAS NOT CROSSING. THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON AND THE OAD WAS ABLE TO CROSS. FOUR LOW SPEED TREATMENTS AND THREE HIGH SPEED TREATMENTS WERE PERFORMED. SUDDENLY, THE OAD STOPPED SPINNING AND STALLED. THE OAD WAS UNABLE TO BE POWERED BACK ON, EVEN IN GLIDEASSIST MODE. LATER, IT WAS OBSERVED THE OAD CROWN WAS DETACHED IN THE DISTAL RCA. ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED COMPONENT, HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT WAS SENT FOR SURGERY TO SUCCESSFULLY REMOVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CAUSE OF THE FRACTURE WAS DUE TO AN OAD STALL. THE TREATMENT WAS PERFORMED DISTAL TO PROXIMAL. THERE WAS NO CLEAR INDICATION AS TO WHAT LED TO THE OAD STALL.

    Description of Event or Problem · 0

    IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING RE-USED FOR A PROCEDURE TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA). THE OAD WAS USED ON A DIFFERENT PATIENT PRIOR TO THIS PROCEDURE. IT WAS INDICATED THE RCA WAS DIFFICULT TO CROSS WITH THE OAD, WITH A GUIDELINER USED IN AN ATTEMPT TO CROSS, HOWEVER, THE OAD STILL WAS NOT CROSSING. THE LESION WAS DILATED WITH AN UNSPECIFIED BALLOON AND THE OAD WAS ABLE TO CROSS. FOUR LOW SPEED TREATMENTS AND THREE HIGH SPEED TREATMENTS WERE PERFORMED. SUDDENLY, THE OAD STOPPED SPINNING AND STALLED. THE OAD WAS UNABLE TO BE POWERED BACK ON, EVEN IN GLIDEASSIST MODE. LATER, IT WAS OBSERVED THE OAD CROWN WAS DETACHED IN THE DISTAL RCA. ATTEMPTS WERE MADE TO RETRIEVE THE FRACTURED COMPONENT, HOWEVER, THIS WAS UNSUCCESSFUL. THE PATIENT WAS SENT FOR SURGERY TO SUCCESSFULLY REMOVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CAUSE OF THE FRACTURE WAS DUE TO AN OAD STALL. THE TREATMENT WAS PERFORMED DISTAL TO PROXIMAL. THERE WAS NO CLEAR INDICATION AS TO WHAT LED TO THE OAD STALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316656 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED DBEC-125 570682-1 10850000491554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention