BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKCAT EXTRACTION CATHETER

    MDR report key: 936388 · Received November 1, 2007

    Report

    Report Number
    2530154-2007-00010
    Event Type
    Injury
    Date Received
    November 1, 2007
    Date of Event
    August 17, 2007
    Report Date
    October 18, 2007
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    DXE
    PMA / PMN Number
    K060092
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTATION OF METHOD CODE: THE ACTUAL QUICKCAT DEVICE USED DURING THE CASE WAS NOT AVAILABLE TO SEND TO KENSEY NASH CORP. FOR EVAL. HOWEVER, A CD-ROM CONTAINING THE ANGIOGRAMS FROM THE CASE WAS PROVIDED. AIR EMBOLUS CAN CLEARLY BE SEEN ON TWO SEPARATE CONTRAST INJECTIONS. HOWEVER, THERE IS NO OBVIOUS CORRELATION ON ANGIOGRAPHY BETWEEN THE USE OF QUICKCAT AND THE AIR EMBOLI.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION IN 2007, THE QUICKCAT EXTRACTION CATHETER WAS USED IN A THROMBOTIC LESION IN A PT'S LAD. AFTER QUICKCAT WAS REMOVED FROM THE GUIDE CATHETER, AN AIR EMBOLUS WAS SEEN WITHIN THE SUBSEQUENT CONTRAST INJECTION. THE QUICKCAT EXTRACTION CATHETER WAS THEN RE-INSERTED AND USED TO EXTRACT THROMBUS IN THE CIRCUMFLEX ARTERY. FOLLOWING THE REMOVAL OF QUICKCAT, ANOTHER AIR EMBOLUS WAS SEEN WITHIN THE NEXT CONTRAST INJECTION. THE PT EXPERIENCED CHEST PAIN, BRADYCARDIA, AND ST ELEVATION. THESE SYMPTOMS WERE SUCCESSFULLY REVERSED WITH MEDICAL MANAGEMENT. THE PT WAS DISCHARGED THREE DAYS LATER. THIS EVENT WAS NOT REPORTED TO THE KENSEY NASH CORP UNTIL OCT. 2, 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKCAT EXTRACTION CATHETER CATHETER, EMBOLECTOMY DXE KENSEY NASH CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention PTCA BALLOONS AND STENT PLACEMENT DURING| THE PROCEDURE.