BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION CATHETER

    MDR report key: 1211524 · Received October 8, 2008

    Report

    Report Number
    2939520-2008-00020
    Event Type
    Other
    Date Received
    October 8, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 7, 2008
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K080891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A PHYSICAL INSPECTION OF THE DEVICE WAS PERFORMED BY A TEAM CONSISTING OF MANUFACTURING ENGINEERING, R&D, AND QA. THE VISUAL INSPECTION LOOKS FOR CATHETER AND SHAFT DAMAGE SUCH AS BENDS, KINKS, CUTS, SCRAPES, CRACKS, DISCOLORATION OR CORROSION. THE CATHETER MUST BE FREE OF ANY MAJOR PHYSICAL DAMAGE BEFORE IT CAN BE ELECTRONICALLY TESTED. DURING THE VISUAL INSPECTION, IT WAS NOTICED THAT THE CATHETER WAS RECEIVED IN TWO PIECES. SEPARATION OF THE CATHETER OCCURRED ALONG THE PROXIMAL CATHETER SHAFT BODY. THE DRIVE CABLE APPEARED TO BE KINKED JUST DISTAL TO THE SEPARATION. THIS KINK INDICATES THE DEVICE MAY NOT BE OPERATIONAL. THERE ARE NO OBSERVED PROCESS OR WORKMANSHIP DEFECTS NOTED ON THE CATHETER. THERE IS NO OBSERVED EVIDENCE TO CONCLUDE THAT THE CATHETER IS OUT OF SPECIFICATION. AT THIS TIME, IT CAN NOT BE DETERMINED WHAT CAUSED THE SEPARATION OF THE CATHETER. ALTHOUGH THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS INCIDENT, IF THE EVENT WERE TO REOCCUR, THERE COULD BE A POTENTIAL FOR INJURY. THIS REPORT IS BEING SENT AS A NOTIFICATION.

    Description of Event or Problem · 1

    A PORTION OF THE DISTAL TUBE WAS SEPARATED FROM THE CATHETER IN A PATIENT DURING A DIAGNOSTIC PROCEDURE. THE CATHETER WAS USED IN THE LAD FOR ISR WITH NO PROBLEMS. A 6FR RUNWAY KIMMY MINI SH GUIDE CATHETER AND A CYPHER 3.5 - 23MM STENT WERE USED IN THE LAD. THE PHYSICIAN NOTICED A 90 DEGREE ANGLE KINK IN THE CATHETER TO WHICH HE STRAIGHTENED. NO DAMAGE OR ISSUES WERE NOTED AFTER STRAIGHTENING THE CATHETER. THE RCA AND LAD#1 WAS IMAGED USING THE SAME GUIDING CATHETER AND THE GUIDE WIRE (PASSLE AR0.8). THE REVOLUTION CATHETER DISPLAYED NORMAL IMAGES AND PULL-BACK. AFTER STENTING, THE CATHETER WAS PULLED OUT OF THE PATIENT BODY AND WAS FOUND TO BE IN TWO PIECES, LEAVING A PORTION IN THE RCA. RECOVERY OF THE PIECE WAS ATTEMPTED WITH A GOOSENECK SNARE (MICROSNARE KIT 4MM). ENSNARE27-45MM, INTRODUCED IN THE RIGHT FEMORAL ARTERY, WAS ABLE TO CATCH THE SEPARATED PART AND REMOVE IT FROM THE PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION CATHETER IVUS CATHETER DQO VOLCANO CORPORATION 89000 035-01936

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention