CAUTION: Federal law (USA) restricts these devices to sale 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 catheters in the Wingman Family of Crossing Catheters (14/14C/18/35 – see specification table above) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. Any one of these catheters 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 Catheters are also intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. In that area, they may also 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 Catheters are contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheters are contraindicated for use in the cerebral vasculature.
Warnings
Hydrophilic wires prone to excessive swelling (e.g., ZipWire) should not be used with Wingman Crossing Catheters.
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 temperatures.
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. Federal law (USA) restricts these devices to sale 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.
