BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    MDR report key: 2191286 · Received July 19, 2011

    Report

    Report Number
    2939520-2011-00048
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 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 THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MFG RELEASED CRITERIA. THE COMPLAINT DATABASE WAS REVIEWED AND TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE DEVICE WAS EVALUATED UPON RETURN AND FOUND THE SEPARATION IN THE PROXIMAL SHAFT APPROX 76.5 CM MEASURING FROM THE TELESCOPE END. THE DRIVE CABLE WAS KINKED AT THE LOCATION OF THE SHAFT SEPARATION, AND THE MONORAIL HAD EVIDENCE OF GUIDE WIRE DAMAGE. THE RESISTANCE FELT BY THE USER WHILE ADVANCING THE IVUS CATHETER IN THE GUIDING CATHETER WAS MOST LIKELY DUE TO THE INTERFERENCE BETWEEN THE INSIDE DIAMETER OF THE GUIDE CATHETER AND THE BENT SECTION OF THE PROXIMAL SHAFT. THERE WAS INSUFFICIENT SPACE BETWEEN THE INSIDE DIAMETER OF THE GUIDING CATHETER AND THE OUTSIDE DIAMETER OF THE PROXIMAL SHAFT; SUBSEQUENTLY, THE DEVICE COULD KINK ENOUGH TO DEFORM THE DRIVE CABLE. THE IFU WARNING FOR THIS DEVICE STATES: DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER. THE IFU PRECAUTION ALSO STATES: DO NOT KINK OR SHARPLY BEND THE CATHETER AT ANY TIME. THIS CAN CAUSE DRIVE CABLE FAILURE. AN INSERTION ANGLE GREATER THAN 45 DEGREES IS CONSIDERED EXCESSIVE. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LESION WAS LAD MIDDLE, AND WITH NO CALCIFICATION. TWO WIRES WERE INSERTED IN A GUIDING CATHETER (6F) AND THE PHYSICIAN FELT RESISTANCE WHILE THE IVUS CATHETER WAS ADVANCING IN THE GUIDING CATHETER. THE SHAFT SEPARATION OCCURRED WHEN PULLING THE CATHETER FROM THE PT'S BODY. THE DISTAL SHAFT REMAINED INSIDE THE GUIDING CATHETER THEREFORE THE IVUS CATHETER, GUIDEWIRES AND GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT FROM THE PT'S BODY. A SECOND CATHETER WAS NOT USED AND THE IVUS PROCEDURE WAS ABORTED. 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 INTRAVASCUALR CATHETER OBJ VOLCANO CORPORATION 89000 035 04607

    Patients

    Seq Age Sex Outcome Treatment
    1