BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMCAT THROMBECTOMY CATHETER

    MDR report key: 793167 · Received December 1, 2006

    Report

    Report Number
    2530154-2006-00011
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 30, 2006
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    DXE
    PMA / PMN Number
    k060016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE BLUE DISTAL TIP WAS RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE FORWARDED TO THE AGENCY TO COMPLETE SECTION AS SOON AS POSSIBLE.

    Description of Event or Problem · 1

    KNC REPRESENTATIVE WAS NOT PRESENT DURING CASE. PHYSICIAN HAD BEEN TRAINED ON THE DEVICE, HOWEVER, THE DEVICE WAS USED OFF LABEL IN A CORONARY PROCEDURE. THROMCAT WAS USED TO REMOVE THROMBUS IN A VERY SMALL TORTUOUS CIRCUMFLEX ARTERY. WHEN REMOVING THE THROMCAT DEVICE IT WAS OBSERVED THAT THE BLUE TIP WAS NOT AT THE END OF THE CATHETER. THE BLUE TIP WAS FOUND IN THE HEMOSTATIC VALVE OF THE TUOHY Y BODY. THE PHYSICIAN WANTED TO DO MORE INTERVENTION, HOWEVER, NOTICED A DISSECTION IN VESSEL AND ABORTED THE REST OF THE PROCEDURE. BASED ON THE PICTURES TAKEN DURING THE REMOVAL OF THE THROMCAT, THE THROMBUS HAD BEEN REMOVED AND THERE HAD BEEN NO DISSECTION OBSERVED. A PT2 AND WHISPERWIRE WERE USED AFTER THE THROMCAT WAS REMOVED. THE DISSECTION WAS OBSERVED AFTER THE WHISPERWIRE WAS USED. PT WAS KEPT AN EXTRA DAY AND THEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMBECTOMY CATHETER THROMBECTOMY DEVICE DXE KENSEY NASH CORP. NA 52414

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O XB3.5| MERIT TUOHY BORST| BMW WIRE| CORDIS 7F BRITE TIP GUIDE| WHISPERWIRE| VOYAGER BALLOON| PT2 WIRE