BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 24279186 · Received February 6, 2026

    Report

    Report Number
    3004742232-2026-00017
    Event Type
    Death
    Date Received
    February 6, 2026
    Date of Event
    January 15, 2026
    Report Date
    April 27, 2026
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    UDI-DI
    10850026568698
    PMA / PMN Number
    P130005
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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, DIFFICULT TO REMOVE, PERFORATION OF VESSELS, MYOCARDIAL INFARCTION, PERICARDIAL EFFUSION, DEATH AND UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. IN THIS CASE, IT IS POSSIBLE THAT THE REPORTED FAILURE TO ADVANCE, DIFFICULT TO REMOVE, PERFORATION OF VESSELS, MYOCARDIAL INFARCTION, PERICARDIAL EFFUSION, DEATH AND UNEXPECTED MEDICAL INTERVENTION WERE DUE TO PATIENT DISEASE STATE AND/OR USE TECHNIQUES EMPLOYED; HOWEVER, SINCE THE DEVICE WAS NOT RETURNED THIS CANNOT BE CONFIRMED. PER REPORTED DETAILS, THE OAD COULD NOT CROSS THE LESION DUE TO CALCIUM. DURING THIS TIME, THE VIPERWIRE GUIDEWIRE RETRACTED BACK INTO THE OAD AND GOT STUCK WITHIN THE OAD. THE RETRACTION OF THE WIRE AND BECOMING STUCK COULD BE AN INDICATION THAT FORCE WAS APPLIED IN AN ATTEMPT TO CROSS THE CALCIFIED LESION. 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 FIELDS: G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS) AND H11.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL VIPERWIRE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A SEVERELY CALCIFIED MODERATELY-TO-SEVERELY TORTUOUS CIRCUMFLEX ARTERY. A VIPERWIRE FLEX TIP CORONARY GUIDEWIRE PASSED WAS ADVANCED DOWN INTO CIRCUMFLEX. THE OAD WAS ADVANCED AND ATTEMPTED TO BE SPUN, BUT COULD NOT CROSS THE LESION DUE TO CALCIUM. DURING THIS TIME, THE VIPERWIRE GUIDEWIRE RETRACTED BACK INTO THE OAD AND GOT STUCK WITHIN THE OAD. THE OAD WAS UNABLE TO BE SPUN. THE OAD WAS SWITCHED TO GLIDEASSIST MODE TO HELP SPIN OUT BUT, AT THAT POINT, WITH THE VIPERWIRE GUIDEWIRE BEING STUCK IN THE OAD CROWN, THE VIPERWIRE GUIDEWIRE SHEARED OFF. A NON-ABBOTT GUIDEWIRE WAS INSERTED INTO THE CIRCUMFLEX TO MAINTAIN ACCESS, HOWEVER, THE OAD WAS UNABLE TO BE REMOVED FROM THE PATIENT. IN THE PHYSICIAN'S OPINION, IT WAS LIKELY THE OAD CROWN WENT OUTSIDE OF THE VESSEL AND CAUSED A PERFORATION. THE PHYSICIAN DID NOT WANT TO CONTINUE TO PULL THE OAD TO WORSEN THE ISSUE. PERICARDIAL EFFUSION DEVELOPED, PERICARDIAL CENTESIS WAS PERFORMED AND 100CC OF BLOOD WAS REMOVED TO RESOLVE THE PERFORATION. THE OAD REMAINED IN THE PATIENT WHILE WAITING FOR THE PATIENT TO BE TRANSFERRED TO ANOTHER HOSPITAL BUT THE PATIENT EXPIRED DURING THIS TIME. IT WAS NOTED THAT THE OAD WAS STUCK AND WAS UNABLE TO BE REMOVED FROM THE VESSEL AND AS THE FACILITY DID NOT HAVE OPEN HEART SURGERY ONSITE, THE PATIENT WAS BEING TRANSFERRED TO ANOTHER HOSPITAL TO HAVE THE DEVICE SURGICALLY REMOVED. THE PHYSICIAN WAS UNSURE OF CAUSE OF DEATH AND STATED IT COULD HAVE BEEN THE PERFORATION OF VESSEL THAT CAUSED THE BLEEDING OR THE OAD THAT WAS STUCK AND EVENTUALLY CLOTTED AND CAUSED A HEART ATTACK. IN THE OPINION OF THE PHYSICIAN, THE PERFORATED WIRE AND THE OAD CONTRIBUTED TO THE DEATH OF THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A SEVERELY CALCIFIED MODERATELY-TO-SEVERELY TORTUOUS CIRCUMFLEX ARTERY. A VIPERWIRE FLEX TIP CORONARY GUIDEWIRE PASSED WAS ADVANCED DOWN INTO CIRCUMFLEX. THE OAD WAS ADVANCED AND ATTEMPTED TO BE SPUN BUT COULD NOT CROSS THE LESION DUE TO CALCIUM. DURING THIS TIME, THE VIPERWIRE GUIDEWIRE RETRACTED BACK INTO THE OAD AND GOT STUCK WITHIN THE OAD. THE OAD WAS UNABLE TO BE SPUN. THE OAD WAS SWITCHED TO GLIDEASSIST MODE TO HELP SPIN OUT BUT, AT THAT POINT, WITH THE VIPERWIRE GUIDEWIRE BEING STUCK IN THE OAD CROWN, THE VIPERWIRE GUIDEWIRE SHEARED OFF. A NON-ABBOTT GUIDEWIRE WAS INSERTED INTO THE CIRCUMFLEX TO MAINTAIN ACCESS, HOWEVER, THE OAD WAS UNABLE TO BE REMOVED FROM THE PATIENT. IN THE PHYSICIAN'S OPINION, IT WAS LIKELY THE OAD CROWN WENT OUTSIDE OF THE VESSEL AND CAUSED A PERFORATION. THE PHYSICIAN DID NOT WANT TO CONTINUE TO PULL THE OAD TO WORSEN THE ISSUE. PERICARDIAL EFFUSION DEVELOPED, PERICARDIAL CENTESIS WAS PERFORMED AND 100CC OF BLOOD WAS REMOVED TO RESOLVE THE PERFORATION. THE OAD REMAINED IN THE PATIENT WHILE WAITING FOR THE PATIENT TO BE TRANSFERRED TO ANOTHER HOSPITAL BUT THE PATIENT EXPIRED DURING THIS TIME. IT WAS NOTED THAT THE OAD WAS STUCK AND WAS UNABLE TO BE REMOVED FROM THE VESSEL AND AS THE FACILITY DID NOT HAVE OPEN HEART SURGERY ONSITE, THE PATIENT WAS BEING TRANSFERRED TO ANOTHER HOSPITAL TO HAVE THE DEVICE SURGICALLY REMOVED. THE PHYSICIAN WAS UNSURE OF CAUSE OF DEATH AND STATED IT COULD HAVE BEEN THE PERFORATION OF VESSEL THAT CAUSED THE BLEEDING OR THE OAD THAT WAS STUCK AND EVENTUALLY CLOTTED AND CAUSED A HEART ATTACK. IN THE OPINION OF THE PHYSICIAN, THE PERFORATED WIRE AND THE OAD CONTRIBUTED TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336576 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED DBEC-125 573025-1 10850026568698

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown Death