BEUDAMED
    FDA Adverse Event Other Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 1725410 · Received June 11, 2010

    Report

    Report Number
    2939520-2010-00022
    Event Type
    Other
    Date Received
    June 11, 2010
    Date of Event
    May 19, 2010
    Report Date
    May 19, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    PMA / PMN Number
    K080891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENTATION AND COMPLAINT HISTORY WERE REVIEWED. (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED TO THE MANUFACTURER SO A DEVICE EVALUATION COULD NOT BE PERFORMED. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD REASONABLY BE EXPECTED TO CONTRIBUTE TO THE REPORTED FAILURE MODE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THERE WAS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UPON COMPLETION OF DIAGNOSIS OF THE MID LAD, AND PRIOR TO TREATMENT, A REVOLUTION IVUS CATHETER BECAME STUCK WITH THE GUIDEWIRE. AS THE GUIDEWIRE WAS BEING WITHDRAWN TOWARDS THE DISTAL TIP OF THE GUIDE CATHETER, THE CATHETER AND GUIDEWIRE BECAME BOUND TOGETHER AT THE CATHETER'S GUIDEWIRE EXIT PORT. THE CATHETER AND THE GUIDEWIRE WERE REMOVED FROM THE PATIENT TOGETHER AS A SINGLE UNIT. THE GUIDEWIRE WAS REPLACED WITH ANOTHER WIRE, BUT AN ALTERNATE IVUS CATHETER WAS NOT USED SINCE THE DOCTOR HAD COMPLETED THE DIAGNOSIS. THE THERAPEUTIC PROCEDURE WAS COMPLETED AS PLANNED. NO ADVERSE EVENTS WERE REPORTED. THIS IS BEING REPORTED AS A NOTIFICATION ONLY. IT IS VOLCANO'S CURRENT POLICY TO REPORT ALL INSTANCES IN WHICH A CATHETER ISSUE CAUSES REMOVAL OR EXCHANGE OF A GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER DIAGNOSTIC INTRAVASCULAR CATHETER OBJ VOLCANO CORPORATION 89000 035 04015

    Patients

    Seq Age Sex Outcome Treatment
    1