BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 3567736 · Received November 8, 2013

    Report

    Report Number
    2939520-2013-00043
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 21, 2013
    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

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS SAME ISSUE WITHIN THIS LOT. THE IVUS CATHETER WAS RETURNED TO VOLCANO CORPORATION FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED AND ALL PARTS WERE FOUND TO BE PRESENT AND INTACT. THE IVUS CATHETER HAD A SLIGHT TEAR AT THE DISTAL END OF THE MONORAIL SECTION, HOWEVER, THERE WAS NO DAMAGE OBSERVED TO THE GUIDEWIRE EXIT PORT. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT PASSED. A CONTROL 0.014" GUIDEWIRE WAS USED TO TEST FOR ANY OBSTRUCTION WITHIN THE CATHETER MONORAIL. THE GUIDEWIRE WAS THREADED THROUGH THE DISTAL END OF THE CATHETER AND OUT THE EXIT PORT WITHOUT ANY RESISTANCE BEING ENCOUNTERED. NO PATIENT INJURY OCCURRED DUE TO THIS INCIDENT. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IVUS RECORDING WHILE REMOVING THE CATHETER FROM INSIDE THE BODY, RESISTANCE WAS ENCOUNTERED AND THE CATHETER BECAME STUCK WITH THE GUIDEWIRE. THE CATHETER AND THE GUIDEWIRE WERE WITHDRAWN AS A UNIT. ALL PORTIONS OF THE CATHETER WERE ACCOUNTED FOR AND THE USER DID NOT REPORT ANY DAMAGE TO THE DEVICE UPON REMOVAL. THE USER DESCRIBED THE TARGET LESION AS A NORMAL LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CATHETER OF THE SAME PRODUCT. NO PATIENT INJURY OCCURRED DUE TO THIS INCIDENT AND THE PATIENT WAS RELEASED FROM THE HOSPITAL AS SCHEDULED. THIS IS BEING REPORTED AS A NOTIFICATION ONLY. IT IS VOLCANO'S POLICY TO REPORT ALL CASES WHERE A CATHETER ISSUE MAY CAUSE REMOVAL OR EXCHANGE OF THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579664 REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 035 05763

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE - RUNTHROUGH NS