BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION CATHETER

    MDR report key: 1211500 · Received October 23, 2008

    Report

    Report Number
    2939520-2008-00024
    Event Type
    Other
    Date Received
    October 23, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 24, 2008
    Manufacturer
    VOLCANO CORPORATION
    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

    THE CATHETER WAS ANALYZED BY MANUFACTURING ENGINEERING, R&D AND QUALITY ENGINEERING. THE CATHETER IS INTACT IN THAT IT REMAINED IN ONE PIECE WITH NO PORTIONS DETERMINED TO BE MISSING. IT APPEARS THAT THE GUIDE WIRE WAS ABLE TO TEAR THROUGH THE MONORAIL SECTION (CORRELATES TO THE REPORTED BURR AS OBSERVED BY THE PHYSICIAN); HOWEVER, THE WIRE DID NOT MAKE IT TO THE POLYIMIDE BAND WHICH PREVENTS TEAR-OUT AND/OR SEPARATION OF THE DEVICE AT THAT LOCATION. THE DISTAL TIP OF THE CATHETER WAS REVIEWED AND THERE WERE NO OBSERVED PROCESS OR WORKMANSHIP DEFECTS FOUND. NO EVIDENCE WAS SEEN THAT WOULD CONCLUDE THE CATHETER WAS MANUFACTURED OUT OF SPECIFICATION. IN THE PAST, A SEVERELY KINKED GUIDE WIRE WAS FOUND TO BE ATTRIBUTED TO A FAILURE MODE SUCH AS THIS. SINCE THE GUIDE WIRE WAS NOT RETURNED WITH THE COMPLAINT PRODUCT, A FINAL DISPOSITION FOR ROOT CAUSE CAN NOT BE DETERMINED. ALTHOUGH THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS INCIDENT, THERE IS A POTENTIAL FOR INJURY SHOULD THIS HAPPEN AGAIN. THIS REPORT IS BEING SENT AS A NOTIFICATION.

    Description of Event or Problem · 1

    THE REVOLUTION CATHETER WAS STUCK IN A VESSEL AFTER VIEWING A LESION AND POBA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION CATHETER IVUS CATHETER DQO VOLCANO CORPORATION 89000 035-01934

    Patients

    Seq Age Sex Outcome Treatment
    1