INSTRUCTIONS FOR USE
Angio-Seal™ Evolution™
Vascular Closure Device
Page 1: ...INSTRUCTIONS FOR USE Angio Seal Evolution Vascular Closure Device ...
Page 2: ...f the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma PRECAUTIONS Special Patient Populations The safety and effectiveness of the Angio Seal Device has not been established in the following patient populations Patients undergoing an interventional procedure who are being treated with warfarin Patients who have known allergies to beef products col...
Page 3: ...infection at the puncture site should be taken seriously and the patient monitored carefully Surgical removal of the device should be considered whenever an access site infection is suspected Collagen deposition into the artery or thrombosis at puncture site If this condition is suspected the diagnosis can be confirmed by duplex ultrasound Treatment of this event may include thrombolysis percutane...
Page 4: ...gnostic angioplasty procedures using a 6 French or smaller procedural sheath The Angio Seal STS was evaluated for safety and efficacy when ambulating patients as soon as possible following device deployment and discharging patients as early as 30 minutes following ambulation Methods Patients who met all inclusion and no exclusion criteria were enrolled during a pre procedure screening evaluation F...
Page 5: ...an angiogram 2 Using sterile technique remove the Angio Seal Device contents from the foil package taking care to pull foil apart completely before removing the Angio Seal Device NOTE The Angio Seal Device must be used within one hour after opening the foil pouch due to the moisture sensitive nature of the product 3 Insert the arteriotomy locator into the Angio Seal insertion sheath Figure 1 makin...
Page 6: ...gure 3 Figure 3 8 From this point advance the arteriotomy locator insertion sheath assembly until blood begins to flow from the drip hole on the locator NOTE Over insertion of the arteriotomy locator insertion sheath assembly into the artery beyond 2 cm may increase the chance of premature anchor hook up or interfere with the anchor s performance to achieve hemostasis If blood flow does not resume...
Page 7: ...on Figure 7 Reference Indicator Carrier Tube Ensure tab is in rear holding position prior to insertion Bypass Tube Hemostatic Valve 2 Confirm that the reference indicator on the insertion sheath is facing up To ensure proper orientation of the Angio Seal Device with the sheath the sheath cap and the device sleeve only fit together in the correct position The reference indicator on the device handl...
Page 8: ...ble NOTE If the device sleeve separates from the sheath while attempting full rear lock positioning do not push the Angio Seal device forward to reattach to the sheath cap Complete sealing of the puncture following instructions in C 1 Figure 10 6 Incorrect Indicator Alignment Distal end of device handle completely covers the white band on the device sleeve Figure 11 If anchor catches prematurely a...
Page 9: ...Pull back on the device handle at the angle of the puncture tract maintaining a steady uninterrupted motion Figure 13 until the colored compaction marker is revealed Figure 14 Pause and assess for hemostasis NOTE If hemostasis is not achieved check to see if the colored compaction marker is exposed If not repeat this step Figure 13 Figure 14 P u l l Compaction Tube Collagen Tissue Artery Sheath Ma...
Page 10: ...ct fails to perform within normal tolerances for a patient due to a defect in materials or workmanship SJM will provide at no charge a replacement SJM product for the patient s use This limited warranty applies only if each of the following conditions is met 1 The product was packaged and labeled by SJM 2 The failed product must be returned to SJM and becomes the property of SJM 3 The product has ...
Page 11: ...RILE R Sterilized by gamma radiation Do not use if temperature indicator dot on package has turned from light grey to dark grey or black Prescription Use Only Manufacture Date Manufacturer Quantity REF Reorder Number Lot Number Vascular Closure Device Vascular Closure Device Accessory Guidewire Product of Ireland Accessory Guidewire Product of Ireland SYMBOLS ...
Page 12: ...NTROL LESS RISK are trademarks and service marks of St Jude Medical Inc and its related companies 2011 St Jude Medical All rights reserved St Jude Medical 14901 DeVeau Place Minnetonka MN 55345 2126 USA Phone 1 888 864 7444 1 952 933 4700 sjm com ART100041600 Ver A 04 2011 ...
