BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 2182605 · Received July 5, 2011

    Report

    Report Number
    2939520-2011-00044
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    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 THE RETURNED 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. THE DEVICE WAS RECEIVED IN TWO PIECES WITH NO MISSING COMPONENTS. THE SEPARATION WAS IN THE OVERLAP BETWEEN THE DISTAL TIP AND PROXIMAL SHAFT. FURTHER EXAM UNDER A HIGH MAGNIFICATION MICROSCOPE REVEALED SEVERAL SCORE MARKS ALONG THE PROXIMAL END OF THE DISTAL TIP AND APPEARED FEATHERED/ELONGATED. BOTH OF THESE ARE BELIEVED TO BE A RESULT OF EFFORTS BY THE USER TO REMOVE THE IVUS CATHETER FROM THE GUIDE CATHETER. THE IFU WARNING FOR THIS DEVICE STATES: "USE OF THE REVOLUTION CATHETERS IS RESTRICTED TO SPECIALISTS WHO ARE FAMILIAR WITH, AND HAVE BEEN TRAINED TO PERFORM, THE PROCEDURES FOR WHICH THIS DEVICE IS INTENDED. DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS." NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS 90% STENOSED IN LCX AND VESSEL WAS SEVERELY TORTUOUS. THE CATHETER WAS INSERTED FROM RA APPROACH. THE IVUS CATHETER COULD NOT CROSS THE LESION. THE DISTAL SHAFT WAS NOTED TO BE DETACHED WHEN THE PHYSICIAN REMOVED THE IVUS CATHETER FROM THE PT BODY. THE DISTAL SHAFT WAS STICKING OUT FROM THE PT BODY. THE DISTAL SHAFT WAS STICKING OUT FROM THE Y CONNECTOR OF THE GUIDE CATHETER HOWEVER IT WAS EASILY REMOVED FROM THE PT'S BODY. THERE WERE NO MISSING OR REMAINING PARTS LEFT INSIDE THE PT. THE PHYSICIAN REPORTED THAT THERE WAS NO RESISTANCE WHILE WITHDRAWING THE IVUS CATHETER. THE GUIDE CATHETER HAS Y CONNECTOR. IN THE Y CONNECTOR OF THE GUIDE CATHETER THERE WAS AN INTRODUCER WITH A GUIDEWIRE INSERTED ALONG WITH THE GUIDEWIRE FOR THE IVUS CATHETER. WHEN THE IVUS CATHETER WAS REMOVED IT DID NOT GET STUCK ON EITHER THE GUIDEWIRE OR THE INTRODUCER. IT WAS REPORTED THAT ANOTHER IVUS CATHETER OF THE SAME PRODUCT FROM THE SAME MFR WAS USED AND THE FAILURE WAS NOT DUPLICATED. THERE WAS NO REPORT OF PT INJURY DUE TO THIS EVENT.

    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 04570

    Patients

    Seq Age Sex Outcome Treatment
    1