BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM ST CATHETER

    MDR report key: 4133002 · Received September 29, 2014

    Report

    Report Number
    2939520-2014-00081
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    VOLCARIA S.R.L.
    Product Code
    OBJ
    PMA / PMN Number
    K120697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE MANUFACTURING DOCUMENTATION FOR THE DEVICE USED IN THIS CASE WAS REVIEWED AND ALL QUALITY AND MANUFACTURING RELEASE CRITERIA WERE MET. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS SAME FAILURE MODE WITHIN THIS LOT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER HOWEVER A FULL EVALUATION WILL BE CONDUCTED WITH THE DEVICE IS RECEIVED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODEL VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES.

    Description of Event or Problem · 1

    THE CATHETER WAS INITIALLY WORKING FINE AS INTENDED. UPON REMOVAL FROM THE GUIDE CATHETER AFTER COMPLETION OF THE CASE, THE STAFF NOTED THAT THE DISTAL SHAFT HAS STARTED TO SPIRAL APART. NO OTHER ISSUES WERE NOTED BY THE USER, THE DEVICE WAS NOT SEPARATED INTO TWO PIECES, AND THERE WERE NO PROTRUDING SECTIONS. THE PROCEDURE HAD BEEN COMPLETED PRIOR TO THE OBSERVATION OF THE "SPIRALING". NO PT INJURY WAS REPORTED, AND O INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606482 EAGLE EYE PLATINUM ST CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCARIA S.R.L. 85900PST 0231 50020462

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: BMW| SHEATH: PINNACLE| GUIDE CATHETER: 6F TERUMO