EKOS—EkoSonic Endovascular Intelligent Drug Delivery Catheters and MicroSonic Devices: Radiopaque Marker Bands May Dislodge during Procedures; MicroSonic Device May Fracture

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In a May 24, 2012, letter submitted by an ECRI Institute member hospital, EKOS states that it has received reports of instances in which the radio-opaque marker bands on the Intelligent Drug Delivery Catheters (IDDCs) below were dislodged during a procedure. An investigation concluded that the marker bands were properly installed during manufacturing but were subjected to undue force during the EkoSonic procedure. Specifically, introducer sheaths with a rotating hemostasis valve (commonly called a "Toughy-Borst") were used during the procedures in which the marker bands were dislodged. Testing has demonstrated that the sealing mechanism in some rotating hemostasis valves may not fully open when the valve is loosened. When the IDDC is withdrawn through such...