BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK

    MDR report key: 10142933 · Received June 10, 2020

    Report

    Report Number
    MW5094948
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 9, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    DURING HIGH SPEED ROTATIONAL ATHERECTOMY IN A PREVIOUSLY STENTED RIGHT CORONARY ARTERY. THE CSI DIAMONDBACK CROWN BECAME STUCK WITHIN THE PREVIOUSLY DEPLOYED STENT. THE CROWN AND STENT WERE REMOVED FROM THE CORONARY TOGETHER WITH SIGNIFICANT TRACTION. THE STENT BECAME DISLODGED AT THE FEMORAL ACCESS SITE IN THE EXTRAVASCULAR SOFT TISSUE. A SEGMENT OF CORONARY WIRE HAD FRACTURED AND WAS FREE IN THE CORONARY ARTERY. IT WAS SNARED AND REMOVED FROM THE ARTERY. AFTER SERIAL BALLOON DILATATIONS, THE RCA WAS SUCCESSFULLY STENTED FROM THE CRUX OF THE PDA TO THE MID VESSEL. AFTER INTRAVASCULAR ULTRASOUND, THE MID VESSEL STENT WAS POST DILATED WITH A 4.5 MM BALLOON WITH EXCELLENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605337 CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK CATHETER, CORONARY, ATHERECTOMY MCX CARDIOVASCULAR SYSTEMS INCORPORATED DBEC-125 291790

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention