BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE GOLD IVUS CATHETER

    MDR report key: 2092957 · Received April 15, 2011

    Report

    Report Number
    2939520-2011-00026
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 16, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K073473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASED CRITERIA. THE COMPLAINT DATABASE WAS REVIEWED AND TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. UPON VISUAL INSPECTION BLOOD WAS OBSERVED INSIDE THE DEVICE. FURTHER MICROSCOPIC VISUAL EXAMINATION REVEALED THE POLYIMIDE PROXIMAL SHAFT EXHIBITED A CUT APPROXIMATELY 28 MM FROM PROXIMAL OF THE EXIT PORT. IN ADDITION, A PUNCTURED INNER LUMEN WAS OBSERVED 25MM FROM THE END OF THE DISTAL TIP. FUNCTIONAL TESTING WAS PERFORMED WITH ALL TESTS MEETING PASSING CRITERIA. DURING OUR INVESTIGATION WE COULD NOT CONCLUSIVELY DETERMINE THE SOURCE OF THE FLUID INGRESS. HOWEVER, WE ARE AWARE THAT INNER PUNCTURED LUMEN IS A KNOWN CAUSE OF FLUID INGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THAT AN ACCEPTABLE IMAGE WAS OBTAINED DURING THE FIRST IMAGING. AFTER STENTING, THE PHYSICIAN TRIED TO IMAGE AGAIN, YET HE WAS UNSUCCESSFUL. AT THIS POINT THE PHYSICIAN OBSERVED BLOOD IN THE CATHETER. ADDITIONAL, INFORMATION WAS OBTAINED AND INDICATED THAT THE PHYSICIAN DID NOT HAVE DIFFICULTY WHEN LOADING THE GUIDE WIRE (0.014" NOT VOLCANO PRODUCT) AND THE CATHETER DID NOT GET STUCK TO ANY LESION OR DEVICE. THERE WAS NO VISIBLE DAMAGE THAT WAS REPORTED AT THE TIME OF THE EVENT. IT WAS NOT REPORTED WHETHER THE CATHETER AND THE GUIDE WIRE WERE REMOVED TOGETHER AS A SYSTEM OR NOT. A SECOND CATHETER WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ADVERSE EVENT OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EYE GOLD IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 85900 002 16045

    Patients

    Seq Age Sex Outcome Treatment
    1