CLINICALLY PROVEN
CTO CROSSING CATHETER

CAUTION: This device is restricted to use by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Complications, and Directions for Use.

Indications for Use

The Wingman Crossing Catheters (14/14C/18/35) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.

The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.

Contraindications

The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.

Warnings

Hydrophilic wires prone to excessive swelling (e.g. ZipWire) should not be used with the Wingman Crossing Catheter.

Single Use only. Do not reuse/resterilize. Reusing the device could result in compromised device performance, cross-infection and other safety related hazards.

Do not use if device is open or packaging is damaged

Never advance, withdraw or rotate an intravascular device against resistance until the cause is determined by fluoroscopy.

This device contains nickel and should not be used in patients with known allergies to nickel.

Precautions

Store in a cool, dry place. Protect from direct sunlight and high temperature.

Use only appropriately sized ancillary device, as shown in the Specifications below.

Maximum Infusion Pressure: 360 psi (2482 kpa)

Use the catheter prior to the “Use By” date specified on the package

The catheter should only be used by physicians qualified to perform percutaneous, vascular interventions.

Precautions to prevent or reduce clotting should be taken when any catheter is used in the vascular system. Use of systemic heparinization and heparinized saline solution should be considered.

Exercise care while handling the catheter during procedure to reduce the possibly of accidental damage, kinking or bending.

Manipulation of the catheter should only occur under fluoroscopy.

Complications

Vascular catheterization and/or vascular intervention may result in complications including but not limited to:

• Vessel dissection, perforation, rupture or total occlusion

• Infection

• Hematoma

• Unstable angina

• Embolism

• Hypo/hypertension

• Acute myocardial infarction

• Arrhythmia, including ventricular fibrillation

• Death

If the catheter is damaged, this product may cut into a blood vessel wall. Extreme caution needs to be taken when removing a damaged device. In the case of complications resulting from the removal of the entire system, stop immediately the procedure, and perform appropriate treatment at the discretion of the physician

©2024 Reflow Medical, Inc. All rights reserved. Reflow Medical, Wingman, and The Pulse of Medical Ingenuity are registered trademarks or trademarks of Reflow Medical, Inc. This device is restricted to use by or on the order of a physician. Refer to the Instructions for Use for a complete listing of the Indications, Contraindications, Warnings, Precautions, Complications, and Directions for Use.