Device Description; Intended Use/Indications For Use; Cautions; Contraindications - OSCOR DESTINO REACH Manual

1. Device Description

The Destino Reach is a Defl ectable Guiding Sheath featuring a handle with rotating collar, that when rotated, defl ects and straightens the distal tip of the sheath.
The sheath has a hemostatic valve, side-port with stopcock, radiopaque distal tip, with fl ush portholes (available in some models).
The dilator has depth markings and snap locks onto the sheath. The dilator has a tapered distal tip and an inner lumen recommended for use with 0.035" to
0.038" guidewire and/or transseptal needle.
Kit Contains: (Please refer to product label for contents):
1. Detino Reach Steerable Guiding Sheath
2. Destino Reach Dilator
3. Guidewire , 0.035"

2. Intended Use/Indications for Use

The steerable guiding sheath, model Destino Reach is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including
but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

3. Cautions

• Device is supplied sterile. Do not use if package has been previously opened or damaged.
• Prior to use, read all package inserts, warnings, precautions, and instructions.
• Procedure must be performed by trained medical personnel well versed in anatomical landmarks, safe technique, and potential complications.
• The product is designed for single use only.
• Do not re-sterilize or reuse. Do not alter the device in any way. Risks of reusing the sheath are: Structural integrity might get compromised, biological tissue
residue leaving pathogenic bacteria, viruses, and other microorganisms could lead to infection in a patient.
• If you have any questions, please call Oscor Inc. at (727) 937-2511.

4. Contraindications

• Known active systemic or local infection
• Known inability to obtain vascular access
• Patients with atrial thrombus or myxoma, or interatrial baffl e or patch
• Patients with obstructed or inadequate vasculature.

5. Adverse Effects

Potential adverse effects related to the use of the steerable sheath include but are not limited to:
• Air Embolism
• Allergic reaction to contrast media
• Aortic puncture
• Arrhythmias
• Arteriovenous fi stula formation
• Atrial septal defect
• Bleeding plexus injury
• Catheter entrapment
• Cardiac tamponade
• Coronary artery spasm and/or damage
• Dislodgement
• Dissection
• Endocarditis
• Heart Block
• Hematoma formation
• Hemorrhage
• Hemothorax
• Infection
• Intimal tear

6. Possible Complications

Arrhythmias may occur during the use of any intracardiac device. Careful monitoring and availability of emergency equipment are mandatory.

7. Precautions

Transvenous device compatibility: Use the steerable sheath only with compatible transvenous devices. Use the appropriate size sheath for the size of the
transvenous device being utilized. Consequences of using the steerable sheath with incompatible devices may include the inability to deliver the transvenous
device or damage to the transvenous device during delivery.
Before you fl ush the sheath:
• Do not connect a power injection syringe to the sideport and inject contrast solution.
• Do not aspirate steerable sheath with a guidewire in place through the hemostatic valve.
• Aspiration with a guidewire through the valve may cause air embolism which can result in signifi cant morbidity or death.
• Use the sideport, located at the handle, to inject contrast solution or fl ush the steerable sheath. The steerable sheath must be thoroughly fl ushed with either
saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.
• Aspiration and fl ushing of the sheath should be performed frequently to help minimize the potential for air embolism.
• For injecting or aspirating through the sheath, use the sideport only with stopcock. Prior to infusion, remove all air using the sideport.
• Indwelling sheath should be internally supported by a catheter, electrode, or dilator.
• Never advance, torque, or withdraw sheath when resistance is met. Determine cause by fl uoroscopy and then take remedial action.
• The following conditions require special care if a transseptal approach is used:
» enlarged aortic root
» marked right atrial enlargement
» small left atrium
» marked distortion of the thoracic confi guration (for example, kyphosis or scoliosis)

8. Necessary Hospital Equipment

• Keep external defi brillation equipment nearby for immediate use during insertion, placement, acute lead system testing, or whenever arrhythmias are pos-
sible or intentionally induced.
• If the patient has left bundle branch block, back up pacing should be readily available during insertion of the steerable sheath assembly. Use of steerable
sheath assembly may cause heart block.

9. Directions for Use

Note: The steerable sheath is designed for temporary use (contemplated implant duration of eight hours or less) within the peripheral, renal and coronary sys-
tems. Proper surgical procedures and sterile techniques are the responsibility of the medical professional. The following procedures are provided for information
only. Each physician must apply the information in these instructions according to professional medical training and experience.
The procedure for using the steerable sheath to gain intracardic, renal or other peripheral access include the following steps:
• 9.1 Preparing the steerable sheath for insertion
• 9.2 General use of the steerable sheath
• 9.3 Transseptal use of the steerable sheath
• 9.4 Defl ecting and straightening the steerable sheath
• 9.5 Removing the steerable sheath

9.1 Preparing Steerable Sheath for Insertion

Warning: The steerable sheath must be thoroughly fl ushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.
1. Remove the steerable sheath and sheath dilator from the sterile package within the sterile fi eld.
2. Verify defl ecting and straightening of the distal section of the steerable sheath using the handle of the sheath. Refer to "Defl ecting and straightening the
• Irregular heart beat
• Local nerve damage
• Mediastinal widening
• Myocardial infarction
• Pacemaker/defi brillator lead displacement
• Perforation
• Pericardial/pleural effusion
• Pneumothorax
• Pseudoaneurysm formation
• Pulmonary edema
• Stroke
• Subclavian artery puncture
• Thromboembolic events
• Thrombophlebitis
• Valve damage
• Vascular occlusion
• Vasovagal reaction
• Vessel damage/Vessel trauma
• Vessel spasm
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