BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMCAT THROMBECTOMY CATHETER

    MDR report key: 872829 · Received June 27, 2007

    Report

    Report Number
    2530154-2007-00005
    Event Type
    Malfunction
    Date Received
    June 27, 2007
    Date of Event
    May 24, 2007
    Report Date
    June 21, 2007
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    MCW
    PMA / PMN Number
    K006016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY TO BE SENT IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THROMCAT DEVICE WAS USED WHEN STENOSIS AND THROMBUS WAS NOTED IN THE SVG TO THE 1ST DIAGONAL ARTERY. THE PHYSICIAN USED A FR. HS GUIDE, .014 CHOICE FLOPPY WIRE, AND A SCREW-ON TUOHY DEVICE. THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS. IT WAS USED TO MAKE ONE RUN IN THE SVG. THE DOTTERING TECHNIQUE WAS USED TO REMOVE THE THROMBUS, HOWEVER, THE DEVICE WAS UNABLE TO ADVANCE ACROSS THE PRIMARY STENOSIS. WHEN THE DEVICE WAS REMOVED FROM THE BODY, THE PHYSICIAN NOTICED THAT THE TIP OF THE THROMCAT HAD SEPARATED FROM THE DEVICE AND WAS STILL ON THE WIRE, OUTSIDE THE TUOHY AND THE BODY. THE TUOHY WAS COMPLETELY OPEN WHEN THE THROMCAT WAS PULLED OUT OF THE BODY AND NO PRESSURE OR STRAIN WAS PUT ON THE TIP OF THE CATHETER AS IT WAS BEING REMOVED. THE PT DID NOT HAVE ANY COMPLICATIONS 24 HOURS POST CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMBECTOMY CATHETER THROMCAT MCW KENSEY NASH CORP. 63000-01 56073

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR