BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIONS PV .014

    MDR report key: 2150783 · Received June 21, 2011

    Report

    Report Number
    2939520-2011-00040
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    March 30, 2011
    Report Date
    June 2, 2011
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFG DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MFG RELEASED CRITERIA. THE COMPLAINT DATABASE WAS REVIEWED AND TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. FURTHER EVAL REVEALED A COLLAPSED INNER LUMEN APPROXIMATELY 18MM FROM DISTAL OF THE EXIT PORT. THE GUIDEWIRE DISTAL END HAD COME OUT APPROX 115MM FROM THE IVUS CATHETER DISTAL TIP. THE GUIDEWIRE COULD NOT BE REMOVED FROM THE DISTAL TIP OF THE IVUS CATHETER WITHOUT CAUSING FURTHER DAMAGE TO THE CATHETER; THEREFORE, FUNCTIONAL TESTING TO CONFIRM THE REPORTED COMPLAINT OF "CATHETER NOT RECOGNIZED" COULD NOT BE PERFORMED. THE COLLAPSED INNER LUMEN IS LIKELY DUE TO USER HANDLING. THE IFU STATES "WHEN INSERTING THE GUIDEWIRE BOTH CATHETER AND WIRE MUST BE STRAIGHT WITH NO BENDS OR KINKS, OR DAMAGE TO INNER LUMEN MAY OCCUR." THIS EVENT IS BEING REPORTED DUE TO THE OBSERVED GUIDEWIRE STUCK WITH THE CATHETER UPON RETURN TO THE MFR, AND THE POTENTIAL THAT BOTH DEVICES WERE REMOVED FROM THE PT AS A SINGLE UNIT. HOWEVER, THE MFR WAS NOT ABLE TO CONFIRM THIS WITH THE USER. IT IS THE MFR'S POLICY TO REPORT CASES WHERE A POTENTIAL DEVICE ISSUE CAUSES REMOVAL OR EXCHANGE OF THE GUIDE WIRE. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IVUS CATHETER WAS NOT RECOGNIZED WHILE IMAGING IN THE ARTERY. THE SECOND CATHETER (PRODUCT TYPE AND MFR UNK) FUNCTIONED AS INTENDED AND ACCOMPLISHED THE IVUS PROCEDURE. THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND VISUAL EXAM REVEALED THAT THE GUIDEWIRE WAS STILL STUCK WITH THE IVUS CATHETER. DURING EVAL OF THE RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE RECEIVED HAD DIFFERENT SERIAL NUMBER (S/N (B)(4)) FROM WHAT WAS ORIGINALLY REPORTED (S/N (B)(4)). ADDITIONAL INFO RECEIVED ON (B)(6) 2011 CONFIRMED THAT THE RETURNED DEVICE WAS INDEED THE DEVICE USED IN THE CASE REPORTED AS "CATHETER NOT RECOGNIZED." THE LESION BEING TREATED WAS IN THE RIGHT CIA WITH 90% STENOSIS. IT WAS REPORTED THAT NO PT INJURY OCCURRED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV .014 INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 85910 063 01220

    Patients

    Seq Age Sex Outcome Treatment
    1