BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 2823701 · Received January 11, 2011

    Report

    Report Number
    2939520-2011-00001
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 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

    (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN RECEIVED BY THE MFR SO A DEVICE EVAL HAS NOT BEEN PERFORMED YET. 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 FAILURE MODE WITHIN THIS LOT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE WAS DIFFICULT TO EXIT THROUGH THE CATHETER'S GUIDE WIRE EXIT PORT. THE GUIDE WIRE WAS INSERTED INTO THE IMAGING CORE SHEATH SEVERAL TIMES. THE PHYSICIAN BENT THE TIP OF THE GUIDE WIRE AND IT CAME OUT FROM THE CATHETER GUIDE WIRE EXIT PORT PRIOR TO INSERTION IN THE ARTERY. IT WAS ALSO REPORTED THAT THE CATHETER GOT STUCK WITH THE STENT WHILE IMAGING IN THE ARTERY AT PORT IVUS. TWO STENTS (2.5 X 30 AND 2.5 X 18) WERE PLACED IN TANDEM AT LCX, AND Y-STENT (3.0 X 30) WAS PLACED AT LAD WHEN THE RO MARKER OF THE CATHETER WAS CROSSING AND OVERLAPPED PART OF THE STENTS. THE PHYSICIAN FELT RESISTANCE WHILE WITHDRAWING THE CATHETER. ADDITIONAL GUIDE WIRE AND BALLOON CATHETER WERE INSERTED IN LAD AND THE CATHETER WAS SUCCESSFULLY REMOVED FROM THE PT BODY. THE STENTS POSITION WERE NOT MOVED. THERE WAS NO PT INJURY.

    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 04334

    Patients

    Seq Age Sex Outcome Treatment
    1 CATHETER - IKAZUCHI 2.5 X 15, KANEKA| GUIDE WIRE - RUNTHROUGH, TERUMO| 3.0 X 30, MEDTRONIC| GUIDE WIRE - WHISPER, AVJ| 2.5 X 18,| STENTS - ENDEAVER 2.5 X 30,