BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 20419099 · Received October 10, 2024

    Report

    Report Number
    3004742232-2024-00353
    Event Type
    Injury
    Date Received
    October 10, 2024
    Date of Event
    September 21, 2024
    Report Date
    October 10, 2024
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491554
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONTINUED: MODEL NUMBER: GWC-12325LG-FT, CATALOG NUMBER: 7-10038-05, LOT NUMBER: 518363-2, UDI: (B)(4), EXPIRATION DATE: 12/31/2025, MANUFACTURING DATE: 12/14/2023. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MATERIAL INSPECTION REVIEW FOR THIS GUIDE WIRE LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY (OAD) WAS BEING USED TO PERFORM ATHERECTOMY ON A LEFT ANTERIOR DESCENDING (LAD) ARTERY AND A HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA). DURING SET UP, THE OAD AND SALINE PUMP WERE CHECKED, AND BOTH FUNCTIONED AS INTENDED. THE VIPERWIRE ADVANCE GUIDE WIRE WITH FLEX TIP WAS FIRST ADVANCED INTO THE LAD. THE OAD WAS USED TO PERFORM EIGHT LOW SPEED TREATMENTS WITH 20-25 SECOND INTERVALS IN BETWEEN. AFTER ORBITAL ATHERECTOMY WAS COMPLETE IN THE LAD, A XIENCE SIERRA 2.5X33 DRUG ELUTING STENT WAS PLACED. NEXT, THE PHYSICIAN TREATED THE RCA. ONE LOW SPEED TREATMENT WAS PERFORMED. ON THE SECOND LOW SPEED TREATMENT, THE PHYSICIAN OBSERVED THE PROXIMAL PART OF THE OAD CROWN WAS BROKEN AND DETACHED IN THE PROXIMAL RCA. THE OAD WAS REMOVED AND THE OAD CROWN WAS RETRIEVED WITH A SNARE. THE PHYSICIAN ALSO OBSERVED THE VIPERWIRE WAS FRACTURED INSIDE THE RCA. NO INTERVENTIONS WERE PERFORMED TO RETRIEVE THE FRACTURED WIRE. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1933350 DIAMONDBACK CORONARY CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 534186-1 10850000491554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O VIPERWIRE ADVANCE GUIDE WIRE WITH FLEXTIP