BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION

    MDR report key: 1149420 · Received September 4, 2008

    Report

    Report Number
    2939520-2008-00018
    Event Type
    Other
    Date Received
    September 4, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 5, 2008
    Manufacturer
    VOLCANO CORP
    Product Code
    DQO
    PMA / PMN Number
    K080891
    Product Problem
    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 DAMAGES 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, JUST PROXIMAL TO THE WINDOW SECTION. THE DRIVE CABLE APPEARED TO BE BENT OR KINKED JUST DISTAL TO THE SEPARATION. THIS KINK INDICATES THE DEVICE MAY NOT BE OPERATIONAL. THE WALL THICKNESS OF THE COMPLAINT SAMPLE WAS MEASURED AT THE THINNEST PERCEIVED AREA AND WAS VERIFIED TO MEET PRODUCT DESIGN SPECIFICATION. IN AN ATTEMPT TO RE-CREATE THE FAILURE, TWO (2) CATHETERS WERE EXCESSIVELY BENT, FROM THAT OF INTENDED USE, AT A 90 DEGREE ANGLE JUST PROXIMAL OF THE TIP ATTACHMENT. AS EXPECTED, BOTH UNITS SEPARATED ONCE THE 90 DEGREE BEND WAS EXCEEDED. THE CABLE WAS THEN INSPECTED AND FOUND TO HAVE A DEFINITE SHARP KINK. 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

    BROKEN SHAFT - A PART OF SHAFT WAS TORN OFF IN A VESSEL. THE REVOLUTION WAS PUT IN A PATIENT BODY AFTER A BALLOON CATHETER WAS EXPANDED AT LESION, AND THE REVOLUTION WAS PULLED OUT AFTER IVUS PROCEDURE. THE PART OF REVOLUTION WAS FOUND TORN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION IVUS IMAGING CATHETER DQO VOLCANO CORP 89000 035-01862

    Patients

    Seq Age Sex Outcome Treatment
    1