BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE EYE PLATINUM ST DIGITAL IVUS CATHETER

    MDR report key: 3879661 · Received April 4, 2014

    Report

    Report Number
    2939520-2014-00024
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 11, 2014
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K092596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED BY THE MANUFACTURER; THEREFORE, A DEVICE EVALUATION HAS NOT BEEN PERFORMED. PER VOLCANO'S MDR CORPORATE POSITION PAPER, THE LOSS OF THE GUIDEWIRE POSITION IS A SAFETY ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE EAGLE EYE PLATINUM ST CATHETER WAS USED FOR AN AMI CASE FOR A THROMBOTIC LESION. THE USER REPORTED THAT DURING PULLBACK INSIDE THE BODY, RESISTANCE WAS MET WITH THE GUIDE WIRE AND THEN THE GUIDE WIRE GOT STUCK IN THE GUIDE WIRE LUMEN OF THE CATHETER. THE CATHETER AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT, RESULTING IN LOSS OF GUIDE WIRE POSITION. ALL PORTIONS OF THE CATHETER WERE ACCOUNTED FOR UPON REMOVAL FROM THE PATIENT. THE LESION WAS REWIRED WITH A NEW GUIDE WIRE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER EAGLE EYE PLATINUM ST CATHETER. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT DUE TO THE DEVICE MALFUNCTION. THE PATIENT WAS RELEASED FROM THE HOSPITAL ACCORDING TO THE ORIGINAL TREATMENT PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204406 EAGLE EYE PLATINUM ST DIGITAL IVUS CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 85900PST 0231 20005778

    Patients

    Seq Age Sex Outcome Treatment
    1