BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM DIGITAL IVUS CATHETER

    MDR report key: 3894263 · Received February 19, 2014

    Report

    Report Number
    2939520-2014-00010
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    VOLCANO S.R.L.
    Product Code
    OBJ
    PMA / PMN Number
    K092596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CLINICAL ASSESSMENT WAS REQUESTED FROM THE MFR'S CLINICAL AFFAIRS WITH THE RESULTS SUMMARIZED BELOW: THERE WAS NO REPORT OF PT INJURY OR ADVERSE EVENT. THE PT WAS DISCHARGED ACCORDING TO THE ORIGINAL TREATMENT PLAN AND THE PT'S CONDITION TODAY IS REPORTED TO BE STABLE. AT THIS TIME, INVESTIGATION RESULTS ARE STILL PENDING THEREFORE NO DETERMINATION AS TO THE CAUSE OF THIS INCIDENT HAS BEEN MADE. ALTHOUGH THE DEVICE WAS BEING USED IN THE INFERIOR VENA CAVA (IVC), WHICH GENERALLY FALLS WITHIN THE DEVICE'S INDICATIONS FOR USE, IT WAS CLEARLY BEING USED TO VISUALIZE PACEMAKER LEADS IN THE CARDIAC TISSUE WHICH IS NOT AN INTENDED USE OF THE DEVICE. CURRENTLY, NOT ENOUGH SAFETY DATA HAS BEEN REPORTED IN SUPPORT OG THE USE OF THIS DEVICE FOR THIS INDICATION. NO OTHER RECENT FILINGS HAVE BEEN REPORTED FOR THIS FAILURE MODE. GIVEN THE NEED FOR CLOSE PROXIMITY OF THE CATHETER TO CARDIAC TISSUE IN LEAD EXTRACTION CASES, THE LOSS OF GUIDE WIRE POSITION IS CONSIDERED HIGH RISK THAN TYPICAL PERIPHERAL USE AND IT IS THE POSITION OF THE COMPANY TO REPORT SUCH AN EVENT. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THIS DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD EXTRACTION CASE, THE EAGLE EYE PLATINUM CATHETER KINKED ON THE GUIDE WIRE WHILE INSERTING INTO THE PT'S BODY. THE PHYSICIAN NOTICED THE KINK WHILE ADVANCING THE CATHETER AND REMOVED THE WIRE AND CATHETER TOGETHER RESULTING IN A LOSS OF GUIDE WIRE POSITION. ALL PORTIONS OF THE CATHETER WERE ACCOUNTED FOR UPON REMOVAL. ACCESS WAS FROM THE FEMORAL VEIN UP INTO THE INFERIOR VENA CAVA (IVC). THERE WAS NO STENOSIS BUT RATHER SCAR TISSUE TO IMAGE AROUND THE LEAD WHICH ALLOWED THE PHYSICIAN TO MITIGATE RISK IN THE REMOVAL OF THE LEAD. THE PHYSICIAN DID NOT FEEL ANY RESISTANCE WHEN ADVANCING OR REMOVING THE CATHETER. THE PHYSICIAN RE-WIRED USING THE SAME WIRE AND COMPLETED THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS. THERE WAS NO REPORT OF PT INJURY OR ADVERSE EVENT. THE PT WAS DISCHARGED ACCORDING TO THE ORIGINAL TREATMENT PLAN AND THE PT'S CONDITION TODAY IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104235 EAGLE EYE PLATINUM DIGITAL IVUS CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO S.R.L. 85900P 0127 50001593

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR