BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHECK FLO INTRODUCER

    MDR report key: 1951360 · Received December 20, 2010

    Report

    Report Number
    1951360
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 18, 2010
    Report Date
    December 20, 2010
    Manufacturer
    COOK
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ADMITTED FOR ABDOMINAL ANEURSYM REPAIR. COOK CHECK-FLO PERFORMER INTRODUCER USED DURING THE CASE BROKE OFF AT INFUSION END DURING CASE WITH NO APPARENT HARM TO THE PATIENT.FROM OP NOTE: ANGIOGRAM WAS PERFORMED FROM THE LEFT GROIN, AND MEASUREMENTS OBTAINED FOR THE ENDOGRAFT DEVICE. A 23 MM X 16 CM X 12 MM DISTAL DIAMETER DEVICE WAS SELECTED FOR THE MAIN BODY AND WAS TO BE DEPLOYED FROM THE LEFT GROIN. FIRST, A STIFF WIRE WAS ADVANCED AND THE 18-FRENCH INTRODUCER SHEATH WAS ADVANCED TO THE REGION OF THE INFRARENAL AORTA WITH MINIMAL DIFFICULTY. THE APPROPRIATE ORIENTATION FOR THE DEVICE WAS SELECTED, AND THE DEVICE WAS ADVANCED. REPEAT INJECTION WAS PERFORMED TO LOCALIZE THE ORIGIN OF THE RENAL ARTERIES AND THE GRAFT WAS THEN DEPLOYED WITHOUT DIFFICULTY. PATIENT TOLERATED PROCEDURE WELL WITH ALL SHEATHS AND WIRES REMOVED AT END OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHECK FLO INTRODUCER INTRODUCER DYB COOK G11672 2517915

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR