V-Trak™ Advanced Indications, Safety, and Warnings

Warnings and Precaution

Warnings and Precautions

Federal law (USA) restricts this device to sale by or on the order of a physician.

• The MCS and HES is sterile and non-pyrogenic unless the unit package is opened or damaged.

• The MCS and HES is intended for single use only. Do not resterilize and/or reuse the device. After use, dispose in accordance with hospital, administrative and/or local government policy. Do not use if the packaging is breached or damaged.

• The MCS and HES must be delivered only through a wire-reinforced microcatheter with a PTFE inner surface coating. Damage to the device may occur and necessitate removal of both the MCS and HES and microcatheter from the patient.

• High quality, digital subtraction fluoroscopic road mapping is mandatory to achieve correct placement of the MCS and HES.

• Do not advance the V-Trak™ delivery pusher with excessive force. Determine the cause of any unusual resistance, remove the MCS and HES and check for damage.

• Advance and retract the MCS and HES device slowly and smoothly. Remove the entire MCS if excessive friction is noted. If excessive friction is noted with a second MCS and HES, check the microcatheter for damage or kinking.

• If repositioning is necessary, take special care to retract the coil under fluoroscopy in a one-to-one motion with the V-Trak™ delivery pusher. If the coil does not move in a one-to-one motion with the V-Trak™ delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break. Gently remove and discard the entire device.

• Due to the delicate nature of the MCS and HES coils, the tortuous vascular pathways that lead to certain aneurysms and vessels, and the varying morphologies of intracranial aneurysms, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential coil breakage and migration.

• If a coil must be retrieved from the vasculature after detachment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter. This could damage the coil and result in device separation. Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously.

• If resistance is encountered while withdrawing a coil that is at an acute angle relative to the microcatheter tip, it is possible to avoid coil stretching or breaking by carefully repositioning the distal tip of the catheter at, or slightly inside, the ostium of the aneurysm. By doing so, the aneurysm and artery act to funnel the coil back into the microcatheter.

• Delivery of multiple MCS and HES coils is usually required to achieve the desired occlusion of some aneurysms or lesions. The desired procedural endpoint is angiographic occlusion.

• The long-term effect of this product on extravascular tissues has not been established so care should be taken to retain this device in the intravascular space.

• Always ensure that at least two Terumo Neuro V-Grip™ detachment controllers are available before starting a MCS and HES procedure.

• The MCS and HES cannot be detached with any power source other than a Terumo Neuro V-Grip™ detachment controller.

• Always advance an appropriately sized guidewire through the microcatheter after detaching the coil and removing the pusher to ensure that no part of the coil remains within the microcatheter.

• Do NOT place the V-Trak™ delivery pusher on a bare metallic surface.

• Always handle the V-Trak™ delivery pusher with surgical gloves.

• Do NOT use in conjunction with radio frequency (RF) devices.

• No modification of this equipment is allowed.