BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY

    MDR report key: 20533259 · Received October 25, 2024

    Report

    Report Number
    3004742232-2024-00347
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 28, 2024
    Report Date
    October 25, 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. UDI: (B)(4). LOT NUMBER: 534624-3. MANUFACTURE DATE: 5/1/2024. 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 DEVICE (OAD) AND VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WERE USED FOR TREATMENT OF HEAVILY CALCIFIED, MODERATELY TORTUOUS LESION IN LEFT CIRCUMFLEX ARTERY (LCX) OSTIUM. FOUR RETROGRADE LOW-SPEED TREATMENTS WERE PERFORMED LASTING TWENTY-FIVE SECONDS EACH. DURING THE FIFTH RETROGRADE TREATMENT, THE OAD CROWN UNEXPECTEDLY JUMPED BACK, STRIKING THE GUIDE CATHETER. THIS SUDDEN MOVEMENT LED TO A DRIVESHAFT FRACTURE AND THE BREAKAGE OF THE WIRE INSIDE THE ARTERY. A SNARE FAILED TO RETRIEVE THE FRACTURED OAD DRIVESHAFT AND GUIDE WIRE. THE FRACTURED OAD DRIVESHAFT AND GUIDE WIRE WERE SUCCESSFULLY PUSHED TO DISTAL BRANCH. STENT PLACEMENT WAS PERFORMED IN PROXIMAL LCX. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818791 DIAMONDBACK CORONARY CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 533205-1 10850000491554

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R VIPERWIRE