BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION CATHETER

    MDR report key: 1001461 · Received February 20, 2008

    Report

    Report Number
    2939520-2008-00003
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    January 16, 2008
    Report Date
    February 12, 2008
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN HAD EXPERIENCED SOME RESISTANCE DURING THE ADVANCEMENT OF THE CATHETER. UPON RETURN OF THE CATHETER, A TEAM CONSISTING OF RAD, QA, AND REGULATORY MET TO EVALUATE THE RETURNED CATHETER. THE CATHETER APPEARED TO HAVE BEEN BUILT PER SPECIFICATION. ALTHOUGH THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO AN INJURY, THERE COULD BE POTENTIAL FOR INJURY SHOULD THE EVENT HAPPEN AGAIN. THIS REPORT IS BEING SENT AS A NOTIFICATION.

    Description of Event or Problem · 1

    THE REVOLUTION CATHETER AND GUIDE WIRE BECAME TANGLED DURING PROCEDURE. THERE WAS NO IMPACT TO THE PT OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION CATHETER IVUS CATHETER DQO VOLCANO CORPORATION 89000 03501503

    Patients

    Seq Age Sex Outcome Treatment
    1