BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 2476782 · Received February 23, 2012

    Report

    Report Number
    2939520-2012-00014
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 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 MANUFACTURING 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 AND THE TWO GUIDEWIRES (DIFFERENT MFR) WERE RETURNED TO VOLCANO CORP. A VISUAL INSPECTION OF THE IVUS CATHETER WAS PERFORMED AND ALL PARTS WERE FOUND TO BE PRESENT AND INTACT. THE TWO RETURNED GUIDEWIRES HAD SEVERE TWIST DAMAGE AT THE FLEXIBLE END. THE IVUS CATHETER HAD TEAR AT THE DISTAL END OF THE EXIT PORT. THE DAMAGE APPEARS TO BE CONSISTENT WITH WHEN THE GUIDE WIRE WAS STUCK IN THE CATHETER; THIS WOULD RESULT INTO GUIDEWIRE ENTANGLEMENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND PASSED. SINCE THE TWO RETURNED GUIDEWIRES WERE TOO DAMAGED TO TEST, A 0.014¿ GUIDEWIRE AVAILABLE IN THE MFR¿S LAB WAS USED TO TEST OF ANY OBSTRUCTION WITHIN THE CATHETER MONORAIL. THE GUIDEWIRE PASSED NORMALLY WITH THE GUIDEWIRE BEING THREADED THROUGH THE DISTAL END OF THE IVUS CATHETER WITHOUT RESISTANCE. THE IFU WARNING 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 GUIDE WIRE TOGETHER AS ONE UNIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO PROBLEMS OCCURRED AT THE FIRST THREE PULLBACKS WITH THE IVUS CATHETER. DURING THE FOURTH INSERTION, THE IVUS CATHETER GOT STUCK WITH THE GUIDEWIRE SO THE IVUS CATHETER AND THE GUIDEWIRE WERE WITHDRAWN TOGETHER AS A UNIT. NO RESISTANCE WAS FELT WITH THE IVUS CATHETER AND THE GUIDE CATHETER. ANOTHER GUIDEWIRE WAS USED AND THE IVUS CATHETER WAS INSERTED BUT THE IVUS CATHETER GOT STUCK WITH THE GUIDEWIRE AGAIN. AS A RESULT, THE GUIDEWIRE AND IVUS CATHETER WERE WITHDRAWN AS A UNIT. THE IVUS PROCEDURE WAS ALMOST COMPLETED SO THE PHYSICIAN DECIDED TO ABORT THE IVUS PROCEDURE. THE TWO GUIDEWIRES USED WERE FROM A DIFFERENT MFR. NO PT INJURY OCCURRED DUE TO THIS INCIDENT AND THE PT WAS RELEASED FROM THE HOSP 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 DIAGNOSTIC INTRAVASCULAR CATHETER OBJ VOLCANO CORPORATION 89000 035 04800

    Patients

    Seq Age Sex Outcome Treatment
    1