BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 21621512 · Received March 17, 2025

    Report

    Report Number
    3004742232-2025-00051
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 3, 2025
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. LITERATURE ATTACHMENT: ORBITAL ATHERECTOMY IN A CALCIFIED RIGHT CORONARY ARTERY: RETRIEVAL OF THE ENTRAPPED CROWN.

    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 MATERIAL SEPARATION, OBSTRUCTION, PERFORATION OF VESSELS, AND RELATED MEDICAL INTERVENTION APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IN THIS CASE, IT IS LIKELY THAT REPORTED ISSUES ARE DUE TO PATIENT DISEASE STATE, AND 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. H6: CODES 4118, 3233, AND 11 NO LONGER APPLY.

    Description of Event or Problem · 0

    IN A PUBLISHED CASE REPORT, IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A SEVERELY CALCIFIED RIGHT CORONARY ARTERY WITH DIFFUSE STENOSIS. LOW AND HIGH-SPEED TREATMENTS WERE PERFORMED. ON A HIGH-SPEED TREATMENT, IT WAS INDICATED THE OAD EXPERIENCED AN ABRUPT HALT. DURING REMOVAL OF THE OAD, A FRACTURE OCCURRED AT THE OAD CROWN, WHICH LED TO THE OAD CROWN BECOMING ENTRAPPED IN-VIVO. ANGIOGRAPHY REVEALED A SEALED PERFORATION IN THE TARGET LESION. DUE TO THE UNAVAILABILITY OF A SNARE, A NON-ABBOTT MICROCATHETER WAS USED OVER THE VIPERWIRE GUIDE WIRE TO TRAP THE OAD CROWN. THE OAD CROWN WAS SUCCESSFULLY REMOVED WITH THE MICROCATHETER. FINAL ANGIOGRAPHY SHOWED A CONCEALED PERFORATION WITH TIMI 2 FLOW.

    Description of Event or Problem · 0

    IN A PUBLISHED CASE REPORT, IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A SEVERELY CALCIFIED RIGHT CORONARY ARTERY WITH DIFFUSE STENOSIS. LOW AND HIGH SPEED TREATMENTS WERE PERFORMED. ON A HIGH SPEED TREATMENT, IT WAS INDICATED THE OAD EXPERIENCED AN ABRUPT HALT. DURING REMOVAL OF THE OAD, A FRACTURE OCCURRED AT THE OAD CROWN, WHICH LED TO THE OAD CROWN BECOMING ENTRAPPED IN-VIVO. ANGIOGRAPHY REVEALED A SEALED PERFORATION IN THE TARGET LESION. DUE TO THE UNAVAILABILITY OF A SNARE, A NON-ABBOTT MICROCATHETER WAS USED OVER THE VIPERWIRE GUIDE WIRE TO TRAP THE OAD CROWN. THE OAD CROWN WAS SUCCESSFULLY REMOVED WITH THE MICROCATHETER. FINAL ANGIOGRAPHY SHOWED A CONCEALED PERFORATION WITH TIMI 2 FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2773 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED UNK DIAMONDBACK 360 CORONARY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention