BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE GOLD DIGITAL IVUS CATHETER

    MDR report key: 3205449 · Received June 28, 2013

    Report

    Report Number
    2939520-2013-00027
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 6, 2013
    Manufacturer
    VOLCANO CORP
    Product Code
    OBJ
    PMA / PMN Number
    K073473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EAGLE EYE GOLD IVUS CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE VISUAL INSPECTION FOUND A MISSING DISTAL TIP. TRACES OF ADHESIVE AND THE UNIBODY WERE PRESENT. THE INNER LUMEN WAS STRETCHED DISTAL TO THE SCANNER AND THE DISTAL SHAFT AND CORE WIRE WERE DAMAGED. BASED ON THE PHYSICAL EXAMINATION OF THE DEVICE, IT APPEARS THE DEVICE MET SEVERE RESISTANCE. THIS TYPE OF FAILURE IS LIKELY DUE TO USER HANDLING. THE IFU FOR THIS DEVICE HAS THE FOLLOWING PRECAUTIONS: PROTECT THE CATHETER TIP FROM IMPACT AND EXCESSIVE FORCE. DO NOT ADVANCE THE GUIDE WIRE AGAINST SIGNIFICANT RESISTANCE. IF BINDING OCCURS BETWEEN THE CATHETER AND THE GUIDE WIRE WHILE INSIDE THE PT, CAREFULLY REMOVE BOTH THE WIRE AND CATHETER AND DO NOT USE. IF RESISTANCE IS ENCOUNTERED DURING PULLBACK, REMOVE THE ENTIRE SYSTEM (GUIDE WIRE, IVUS CATHETER, AND SHEATH/GUIDE CATHETER) AT THE SAME TIME. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, THERE IS NO OTHER COMPLAINT REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IVUS CATHETER BECAME STUCK WITH AN ASAHI GRAND SLAM 300 CM GUIDEWIRE WHILE THE USER WAS ATTEMPTING TO COMPLETE A PULLBACK. THERE WERE NUMEROUS ATTEMPTS TO SEPARATE THE CATHETER FROM THE GUIDEWIRE AND EVENTUALLY BOTH THE CATHETER AND THE GUIDEWIRE WERE REMOVED AS A SINGLE UNIT. IT WAS REPORTED THAT NO DAMAGE WAS OBSERVED ON THE CATHETER OR GUIDEWIRE WHEN REMOVED FROM THE PT. ANOTHER SAME PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURY OR ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295954 EAGLE EYE GOLD DIGITAL IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORP 85900 002 17291

    Patients

    Seq Age Sex Outcome Treatment
    1 ASAHI GRAND SLAM 300 CM