BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 22564400 · Received July 22, 2025

    Report

    Report Number
    22564400
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 10, 2025
    Report Date
    July 16, 2025
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VIPER WIRE (FROM THE ORBITAL ATHERECTOMY SYSTEM- DIAMONDBACK DEVICE) FRACTURED AND SHEARED OFF INTO THE VESSEL AND REMAINED IN OBTUSE MARGINAL ARTERY. THERE IS DISTAL TIP DETACHMENT OF VIPERWIRE, THERE WAS NO OPTION OF RETRIEVING IT DUE TO SEVERE STENOSIS IN PROXIMAL VESSEL AND DISTAL LOCATION OF THE WIRE TIP. WE DECIDED TO TREAT BY PLACEMENT OF DES [DRUG-ELUTING STENT] AND TRAPPING THE WIRE BEYOND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1713420 DIAMONDBACK CORONARY CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS, INC. GWC-12325LG-FT 558783-3

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other