Convoy® Advanced Delivery Sheath Kits

Prescriptive Information

Contraindications
The use of this kit is contraindicated in:
• Insertion of the Convoy Advanced Delivery Sheath is contraindicated from the femoral approach in patients who have vena cava embolic protection filter devices, or from a leg with known femoral thrombus.
• Transseptal approach in patients with atrial thrombus or myxoma, or interatrial baffle of patch
• Known active systemic or local infection
• Known inability to obtain vascular access.

Warnings
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative.

• For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
• After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
• Do not reprocess, re-sterilize, or reuse. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device. Reuse may cause patient injury and/or the communication of infectious disease(s) from one patient to another.
• The device(s) should be used by physicians thoroughly trained in the techniques of invasive cardiology or electrophysiology techniques. Only those physicians who are specially trained in transseptal procedures should use this device.
• Expel all air from the sheath before use. Do not create a vacuum in the sheath. Remove components and make catheter exchanges slowly.
• Fibrin may accumulate in or on the sheath tip during the procedure. Aspirate when removing dilator, probe, or catheter.
• Remove dilator or catheter slowly: rapid removal may damage valve components resulting in blood flow through the valve, and could create a vacuum that may allow air to enter the sheath.
• The transseptal procedure presents the potential risk for an air embolus which may involve the coronary arteries. Frequently aspirate and flush the sheath, dilator, and catheter during use. A continuous heparinized infusion, under pressure, through the sheath side-port is strongly recommended.
• Use the side-port for injection or aspiration of the sheath, hemostasis valve and sideport assembly. Ensure the stopcock is in the closed position after flushing to prevent back-flow.
• Care must be taken to avoid damage to the vasculature through which the guiding sheath passes. The guiding sheath may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
• When the sheath is left in the vessel, a continuous heparinized infusion under pressure is strongly recommended through the sheath sideport to minimize the potential for thromboembolic events.
• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated or tolerated.
• Direct percutaneous insertion of the Sheath requires the use of the dilator to minimize the potential risk of vessel injury due to a flared tip.
Manipulate sheath carefully when any implantable cardiac device is present: this will minimize the potential of displaced or dislodged leads.
• Catheter entrapment within the heart or blood vessels is a possible complication of cardiac procedures. The potential for catheter entrapment may be increased when the catheter is positioned near the chordae tendineae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue.
• Never advance, torque or withdraw the dilator, guidewire, or sheath when resistance is met, as this may cause catheter entrapment or cardiac perforation. Determine the source of the resistance and take remedial action.
• Visually monitor the location of the distal tip using the radiopaque marker under fluoroscopy, especially when using a transseptal approach. When advancing across a valve, a guidewire or pigtail catheter should be used.
• Most electrophysiology procedures requiring sheaths have the potential for x-ray exposure. Prolonged x-ray exposure can increase risk for acute radiation injury and genetic and somatic effects in patients and laboratory staff. Care should be taken to minimize radiation exposure. Careful consideration should be given before using in pregnant women.
• Arrhythmias may occur during the use of any intracardiac device. Carefully monitor patient and have emergency equipment readily available.
• Manipulate sheath carefully when any implantable cardiac device is present:
• Enlarged aortic root
• Marked right atrial enlargement
• Small left atrium
• Marked distortion of the thoracic configuration (e.g. scoliosis)

Precautions
• Do not autoclave. Exposure to temperatures above 54° C (130° F) may damage the sheath.
• The sheath should be internally supported at all times by a catheter or dilator.
• Use color coding of the sheath and dilator hubs to ensure appropriate size choice and matching of sheath and dilator.
• Before inserting the device into the patient, pre-assemble the sheath and dilator. Insert the needle and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly.
• Use only a Brockenbrough™ type curved needle.
• When using the sheath in the presence of radiofrequency ablation, ensure that all ablating elements are outside the sheath.
• Handle sheath and dilator carefully. Do not bend or kink.
• Do not expose the contents of the sheath kit to organic solvents.
• Store in a cool, dry, dark place.
• Do not alter the devices in this kit.

Adverse Reactions
Adverse reactions may include, but are not limited to:
• Aortic Puncture
• Arrhythmias
• Atrial Septal Defect
• AV Fistula Formation
• Cardiac Or Respiratory Arrest
• Catheter Entrapment
• Coronary Artery Spasm And/Or Damage
• Death
• Dissection
• Drug reaction, allergic reaction to contrast medium
• Embolus (including air)
• Hematoma
• Hemorrhage
• Hypo/hypertension
• Infection
• Local Nerve Damage
• Myocardial Infarction
• Myocardial Ischemia
• Pacemaker/Defibrillator Lead Displacement
• Perforation
• Perforation And/Or Tamponade
• Pericardial/Pleural Effusion
• Phlebitis
• Pseudoaneurysm Formation
• Pulmonary Edema
• Stroke/Transient Ischemic Attack (TIA)
• Thromboembolic Event
• Valve Damage
• Vasovagal Reaction
• Vessel Trauma
• Vessel Spasm
Caution
Federal Law (USA) restricts this device to sale by or on the order of a physician. Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions noted in these instructions. Failure to do so may result in patient complications. Boston Scientific relies on the physician to determine, assess and communicate to each patient all foreseeable risks of the procedure.

Trademark
Convoy and Ultra ICE are trademarks and Constellation is a registered trademark of Boston Scientific Corporation or its affiliates.