BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER 14S

    MDR report key: 2183478 · Received July 18, 2011

    Report

    Report Number
    2183478
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 18, 2011
    Manufacturer
    FLOWCARDIA
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS UNABLE TO PASS A CROSSER CATHETER OVER THE WIRE, WOULD NOT LOAD ON THE BACK OF THE WIRE OR WOULD NOT ALLOW THE WIRE TO BE BACK FED. THE RIGHT SUPERFICIAL FEMORAL ARTERY WAS EASILY CROSSED WITH THE CROSSER 14 ATHERECTOMY DEVICE. THIS WAS PERFORMED WITH A 014 WIRE AND THEN WE SWITCHED OVER TO AN ANGLED GLIDE CATHETER TO A V18 WIRE. THE PHYSICIAN IS VERY FAMILIAR WITH THE USE OF THIS PRODUCT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSER 14S CATHETER, PERCUTANEOUS, CHRONIC TOTAL OCCLUSION DQY FLOWCARDIA * FCVA10033

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR