BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

    MDR report key: 3956948 · Received June 18, 2014

    Report

    Report Number
    2939520-2014-00051
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 19, 2014
    Manufacturer
    VOLCARIA S.R.L.,
    Product Code
    OBJ
    PMA / PMN Number
    K092596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THE DEVICE USED IN THIS CASE WAS REVIEWED AND ALL QUALITY AND MANUFACTURING RELEASE CRITERIA WERE MET. IN ADDITION, THE COMPLAINT DATABASE WAS REVIEWED AND NO ADDITIONAL REPORTS OF THIS TYPE WERE FOUND FOR THIS LOT. THE FAILURE INVESTIGATION PROCESS CONFIRMED THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICE CAUSE THE USER TO INSPECT THE DEVICE FOR BENDS, KINKS OR OTHER DAMAGE PRIOR TO USE AND NOT TO ADVANCE THE GUIDEWIRE AGAINST SIGNIFICANT RESISTANCE. THE LIKELY MECHANISM OF THE FAILURE IS DAMAGE TO THE GUIDEWIRE (KINKING) RESULTING IN THE RESISTANCE EXPERIENCED BY THE USER. ALTHOUGH WE ARE UNABLE TO DEFINITIVELY DETERMINE THE POINT IN THE PROCEDURE WHERE THE GUIDEWIRE BECAME DAMAGED, VOLCANO'S CORPORATE POSITION DEEMS THIS FAILURE MODE AS A POTENTIAL SAFETY ISSUE WHEN THE CATHETER AND GUIDEWIRE HAVE TO BE REMOVED AS A SINGLE UNIT. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES. NO FURTHER ACTION IS REQUIRED OR ANTICIPATED AT THIS TIME.

    Description of Event or Problem · 1

    DURING PULLBACK THE USER ENCOUNTERED SOME RESISTANCE IN GUIDEWIRE MOVEMENT. CONSEQUENTLY, THE USER DECIDED TO REMOVE THE CATHETER AND THE GUIDEWIRE FROM THE PATIENT AS ONE UNIT AND ABORT THE IVUS PROCEDURE. AFTER REMOVAL, THE USER REPORTED THAT BOTH THE CATHETER AND GUIDEWIRE APPEARED DAMAGED. NO PATIENT INJURY OR ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358242 EAGLE EYE PLATINUM DIGITAL IVUS CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCARIA S.R.L., 85900PJ 0133 50006305

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER (JR3.5, SHEATHLESS, 6.5F BY COPERNICUS)| GUIDEWIRE (CORSO BY ST. JUDE MEDICAL)| ANGIOPLASTY CATHETER(SHARED 3.5 4FR BY TECHNOWOOD)| STENT (MULTI-LINK 8 3.0-15)