BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

    MDR report key: 3243128 · Received July 18, 2013

    Report

    Report Number
    2939520-2013-00032
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE MFR FOR EVALUATION. THE EAGLE EYE PLATINUM WAS INSPECTED AND A ZIPPERED TEAR IN THE DISTAL SHAFT UP TO THE EXIT PORT, AN EXPOSED CORE WIRE AND TRACES OF BLOOD IN THE DISTAL SHAFT WERE OBSERVED. WE WERE UNABLE TO PERFORM THE GUIDE WIRE MOVEMENT TEST FOR RESISTANCE, DUE TO THE DAMAGED CONDITION OF THE DEVICE. THE REPORTED COMPLAINT OF RESISTANCE WAS CONFIRMED BASED ON THE DAMAGED CONDITION OF THE DEVICE. THE DAMAGE OBSERVED IS MOST LIKELY THE CAUSE OF USER HANDLING AND A RESULT OF THE IVUS CATHETER BECOMING STUCK ON THE GUIDE WIRE AND THE ATTEMPTS MADE TO DISENGAGE THE IVUS CATHETER FROM THE GUIDE WIRE AS WAS REPORTED BY THE CUSTOMER. THE MFG DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MFG RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FROM THIS FAILURE MODE WITHIN THIS LOT. THE IFU FOR EAGLE EYE PLATINUM STATES TO ALWAYS OBSERVE THE FOLLOWING PRECAUTIONS: "WHEN INSERTING THE GUIDE WIRE BOTH CATHETER AND WIRE MUST BE STRAIGHT WITH NO BENDS OR KINKS, OR DAMAGE TO INNER LUMEN MAY OCCUR". NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EAGLE EYE PLATINUM CATHETER WORKED AS INTENDED ON THE FIRST IVUS, AND WHEN REMOVING THE DEVICE FROM THE PT, THE DOCTOR NOTED SIGNIFICANT RESISTANCE. THE GUIDE WIRE AND THE CATHETER WERE REMOVED AS A SINGLE UNIT. AFTER REMOVAL, THE RAPID EXCHANGE PORT APPEARED TO BE RIPPED FROM THE DISTAL PORT HALFWAY UP THE CATHETER. A SECOND EAGLE EYE PLATINUM CATHETER WAS USED TO COMPLETE THE PROCEDURE. ADD'L INFO INDICATED THAT THE EAGLE EYE PLATINUM WAS PLACED THROUGH AN 8FR SHEATH AND INTRODUCED TO THE SUBCLAVIAN VEIN OVER A .014 GUIDEWIRE. IT DID NOT APPEAR TO BE STUCK. THE SUBCLAVIAN VEIN WAS APPROXIMATELY 12MM IN DIAMETER WITH 80% STENOSIS, AND WAS A STRAIGHT SHOT UP THE VENA CAVA FROM THE FEMORAL VEIN WITH MINIMAL TORTUOSITY. THE DAMAGE TO THE EAGLE EYE PLATINUM WAS FIRST NOTICED WHEN THE WIRE AND CATHETER WERE RETRIEVED FROM THE SHEATH. THE CASE WAS COMPLETED VIA ANGIOPLASTY AND NEW EAGLE EYE PLATINUM CATHETER. NO PT INJURY OR ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335358 EAGLE EYE PLATINUM DIGITAL IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 85900P 127 50038

    Patients

    Seq Age Sex Outcome Treatment
    1