LeMaitre Periscope Instrucciones De Uso página 2

Periscope™ Dissector
(Model Numbers 4200-00, e4200-00)
Remote Endarterectomy Device
Instructions for Use - English
Device Description
The Periscope™ Dissector consists of two principal components, a shaft with an
angled spatula at the distal end and a hollow flexible needle running the full
length of the shaft to the spatula. The shaft and angled spatula are constructed
of stainless steel while the hollow needle is made of nickel titanium. The inner
lumen of the shaft extends from the handle to the palm of the spatula.
The Periscope Dissector is available in one size. The useable length of the
spatula/shaft is approximately 40 cm and the hollow needle can accommodate
up to a 0.018" diameter guidewire.
Indications and Usage
The Periscope Dissector is intended for remote intraluminal stripping of
peripheral blood vessels during vascular reconstruction and to provide a
conduit for guidewire placement.
General indications for peripheral vessel reconstruction include disabling
claudication, ischemic pain at rest, ischemic skin lesions or gangrene.
Indications for endarterectomy specifically as a procedure for vessel
reconstruction include localized lesions and heavy circumferential plaque
deposits.
Contraindications
• Contraindications include, but are not limited to:
• Any evidence of aneurysmal change or severe calcification may
contraindicate endarterectomy since continued aneurysmal degeneration
of the adventitia may be expected.
• In some cases, the vessel wall layers may be quite coherent and the plaque
segment may be difficult to separate from the vessel wall. When the vessel
is in this state of disease, it is often advisable to abandon endarterectomy
and consider an alternative method of vascular reconstruction.
• Use of this device is contraindicated in the coronary, internal carotid
arteries and other vessels of the central circulatory system.
Warnings and Precautions
The Periscope Dissector may only be used by physicians trained in vascular
surgery, specifically endarterectomy procedures. The techniques described
herein are offered to clinicians as a guide.
Periscope Dissector - Handling Precautions
Always inspect the sterile packaging before use. If the packaging is damaged,
do not use the product and contact your LeMaitre Vascular representative.
Do not re-sterilize the Periscope Dissector or the hollow needle.
The Periscope Dissector must be used prior to the "Use By" date printed on the
package.
Periscope Dissector - Use Precautions
Always use fluoroscopy when advancing or manipulating endovascular devices.
Do not attempt to forcibly advance the Periscope Dissector.
Confirm that the Periscope Dissector is properly oriented and the tip of the
hollow needle remains retracted within the shaft while advancing the device
into the vessel.
Use of the Periscope Dissector may lead to vessel perforation requiring
additional interventional procedures (e.g., bypass graft surgery of the artery).
Potential Adverse Events
Adverse events potentially associated with the use of the Periscope Dissector
(e.g., all complications associated with PTA, remote endarterectomy or
atherectomy procedures,) include but are not limited to the following:
• Incisional/puncture site inflammation, hematoma or bleeding