BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMCAT THROMBECTOMY CATHETER

    MDR report key: 851763 · Received May 17, 2007

    Report

    Report Number
    2530154-2007-00003
    Event Type
    Malfunction
    Date Received
    May 17, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 17, 2007
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    MCW
    PMA / PMN Number
    K060016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL HAS NOT BEEN COMPLETED AND WILL BE SENT IN A F/U REPORT.

    Description of Event or Problem · 1

    ONE THROMCAT KIT WAS USED TO TREAT THROMBUS IN AN SVC-LAD VESSEL SEGMENT. THE DEVICE WAS PREPPED PROPERLY AND ADVANCED WITHOUT DIFFICULTY. AFTER ABOUT 30 SECONDS, THE OPERATORS COULD HEAR THAT THE HELIX HAD BROKEN AND SAW THAT IT WAS NOT MOVING ON FLUORO. THE DEVICE WAS REMOVED AND WOULD NOT EXTRACT FLUID WHEN RUN IN A SALINE BOWL. THE OUTER HOUSING WAS ALSO OBSERVED TO BE BROKEN. A NEW DEVICE FROM THE SAME LOT WAS THEN USED FOR THE PROCEDURE WITH ACCEPTABLE PERFORMANCE. NO PT INJURY AS A RESULT, DISCHARGED FROM HOSPITAL THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMBECTOMY CATHETER THROMCAT MCW KENSEY NASH CORP. 63000-01 57126

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR SECOND THROMCAT| DES