BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION CATHETER

    MDR report key: 1033196 · Received April 23, 2008

    Report

    Report Number
    2939520-2008-00006
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 23, 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

    UPON RECEIPT OF THE RETURNED CATHETER, THE CATHETER WAS ANALYZED BY MANUFACTURING ENGINEERING, R&D, QUALITY ENGINEERING, AND REGULATORY. THE CATHETER GUIDE WIRE WAS SEVERELY BENT (90 DEGREES) APPROX 15MM FROM THE DISTAL TIP OF THE GUIDE WIRE. AS RECEIVED FROM THE CUSTOMER, THE GUIDEWIRE WAS ATTACHED TO THE CATHETER. THROMBUS WAS OBSERVED AT THE GUIDEWIRE/CATHETER INTERFACE. IT WAS NOTED THAT THE GUIDE WIRE DID NOT SLIDE SMOOTHLY ALONG THE CATHETER, HOWEVER, IT DID SLIDE WITHOUT SEVERELY BENDING OR KINKING. NO EVIDENCE WAS SEEN THAT INDICATED A MATERIAL FAILURE OR THAT WOULD LEAD TO THE CONCLUSION THAT THE CATHETER WAS OUT OF 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

    AFTER THE INTERVENTION WAS COMPLETED, AN ADD'L PULLBACK WAS PERFORMED AND THE PHYSICIAN ATTEMPTED TO REMOVE THE REVOLUTION CATHETER, BUT WAS NOT ABLE TO DO SO. THE PHYSICIAN REPORTED THAT THE WIRE WAS STUCK ON THE CATHETER. AFTER MANIPULATING THE DEVICES, THE PHYSICIAN WAS ABLE TO PULL BOTH THE WIRE AND CATHETER OUT AT THE SAME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION CATHETER IVUS CATHETER DQO VOLCANO CORPORATION 89000 03501592

    Patients

    Seq Age Sex Outcome Treatment
    1