BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 2864465 · Received December 5, 2012

    Report

    Report Number
    2939520-2012-00073
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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 MFG DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MFG RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS SAME ISSUE WITHIN THIS LOT. THE IVUS CATHETER WAS RETURNED TO VOLCANO CORP FOR EVAL; HOWEVER, THE GUIDE WIRE WAS NOT SUBMITTED FOR EVAL. 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 GUIDE WIRE EXIT PORT. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND IT PASSED. A CONTROL 0.014¿ GUIDE WIRE WAS USED TO TEST FOR ANY OBSTRUCTION WITHIN THE CATHETER MONORAIL. THE GUIDE WIRE WAS THREADED THROUGH THE DISTAL END OF THE CATHETER AND OUT THE EXIT PORT WITHOUT ANY RESISTANCE BEING ENCOUNTERED. THE IFU WARNING FOR THIS DEVICE STATES ¿DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED.¿ IN ADDITION THE IFU CAUTION STATES: ¿IF THE CATHETER IS ADVANCED TOO NEAR THE END OF THE GUIDE WIRE, ADVANCE THE GUIDE WIRE WHILE HOLDING THE IMAGING CATHETER STEADY. IF THIS FAILS, WITHDRAW THE CATHETER AND GUIDE WIRE TOGETHER.¿ UPON GUIDE WIRE ENTRAPMENT, THE PHYSICIAN FOLLOWED THE IFU AND REMOVED THE CATHETER AND GUIDE WIRE TOGETHER AS ONE UNIT. NO PATIENT INJURY OCCURRED DUE TO THIS INCIDENT. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-IVUS WHILE REMOVING THE CATHETER FROM INSIDE THE BODY, THE CATHETER BECAME STUCK WITH THE GUIDE WIRE AND THE CATHETER AND THE GUIDE WIRE WERE WITHDRAWN AS A UNIT. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER UPON REMOVAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER CATHETER OF THE SAME PRODUCT AND A NEW GUIDE WIRE. NO PATIENT INJURY OCCURRED DUE TO THIS INCIDENT AND THE PT 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
    1 REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ VOLCANO CORPORATION 89000 035 04980

    Patients

    Seq Age Sex Outcome Treatment
    1