BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 21945322 · Received May 1, 2025

    Report

    Report Number
    3004742232-2025-00114
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    November 27, 2017
    Report Date
    May 16, 2025
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED PATIENT MYOCARDIAL INFARCTION, OBSTRUCTION/OCCLUSION AND SERIOUS INJURY APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. IN THIS CASE IT IS LIKELY THAT THE REPORTED PATIENT MYOCARDIAL INFARCTION, OBSTRUCTION/OCCLUSION AND SERIOUS INJURY ARE A RESULT OF THE PATIENT¿S DISEASE SEVERITY COMBINED AND/OR USE TECHNIQUES EMPLOYED; HOWEVER, SINCE THE DEVICE WAS NOT RETURNED THIS COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 0

    ECL-033-003 - IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 95% STENOSED, HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). ONE LOW SPEED TREATMENT WAS PERFORMED. THERE WERE NO DEVICE MALFUNCTIONS OR PATIENT COMPLICATIONS REPORTED POST ORBITAL ATHERECTOMY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED TO A MYOCARDIAL INFARCTION, AS SIDE BRANCH OCCLUSION WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 95% STENOSED, HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). ONE LOW SPEED TREATMENT WAS PERFORMED. THERE WERE NO DEVICE MALFUNCTIONS OR PATIENT COMPLICATIONS REPORTED POST ORBITAL ATHERECTOMY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED TO A MYOCARDIAL INFARCTION, AS SIDE BRANCH OCCLUSION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655878 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED UNK DIAMONDBACK 360 CORONARY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other