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Summary of Contents for Terumo Angio-Seal VIP
- Page 1 INSTRUCTIONS FOR USE Angio-Seal™ VIP Vascular Closure Device 610130, 610131...
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Page 2: Device Description
TO ENSURE PROPER DEPLOYMENT AND USE OF THIS DEVICE AND TO PREVENT INJURY TO PATIENTS, READ ALL INFORMATION CONTAINED IN THESE INSTRUCTIONS FOR USE. CAUTION: Federal law restricts this device to sale by or on the order of a physician. The instructions for use is recyclable. -
Page 3: Adverse Events
ADVERSE EVENTS Table 1: Percentage of Patients Experiencing Adverse Events Adverse Event 8F/6F Diagnostic Interventional Interventional (n=97) (n=106) (n=103) Minor Complication AV Fistula Deep Vein Thrombosis Vasovagal Response Device Non-Deployment Device Malfunction Major Complication Vascular Repair Any Complication ‡ Major Complication •... - Page 4 CLINICAL TRIALS Safety and Effectiveness Study clinically indicated for a diagnostic or an interventional cardiac procedure involving access through the femoral artery using an 8F sheath or smaller for the 8F Angio-Seal or a 6F sheath Effectiveness Results Table 2: Time to Hemostasis Time to Hemostasis Diagnostic 8F Interventional...
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Page 5: How Supplied
Results: Table 4: Results of Early Ambulation and Discharge Study Endpoint Study Patients Time to ambulation Range 1 to 323 Time to discharge Range 38 to 368 Time to discharge Range 20 to 120 Endpoint Study Patients Minor complications Conclusions: HOW SUPPLIED •... - Page 6 Reference Indicator Insertion Sheath Arteriotomy Insertion Sheath Fig. 1 Insertion Sheath Fig. 2 NOTE: When resistance is encountered at the anterior vessel wall during over-the-guidewire advancement of the Angio-Seal locator/insertion sheath assembly, rotate the assembly 90 degrees so the reference indicator is facing away from the user. This places the beveled tip of the insertion sheath perpendicular to the anterior vessel wall.
- Page 7 Arteriotomy Insertion Sheath Fig. 4 Insertion Sheath Patient Fig. 5 WARNING: Under normal conditions, the Angio-Seal™ insertion sheath should not move into or out of the artery for the remainder of the Angio-Seal™ device deployment procedure. Using the sheath markings as a guide, ensure that the sheath position has not changed. If re-advancement is necessary, the guidewire and puncture locator must be inserted prior to advancing the Angio-Seal insertion sheath.
- Page 8 Fig. 8 NOTE: If significant resistance to carrier tube advancement is encountered when insertion is almost complete, the anchor may be impinging on the posterior wall of the artery. DO NOT CONTINUE TO ATTEMPT TO ADVANCE. In this case, slight repositioning of the sheath, either by reducing the angle of the sheath with respect to the skin surface or by pulling the sheath back by 1-2 mm, may permit normal deployment.
- Page 9 C. Seal the Puncture NOTE: Do not re-insert the device. Re-insertion of the device after partial deployment could cause collagen to be deposited in the artery. Fig. 12 Fig. 13 WARNING: Failure to maintain tension on the suture while advancing the collagen could cause the collagen to enter the artery. Fig.
- Page 10 Fig. 15 Fig. 16 NOTE: The black compaction marker is usually exposed. If not, repeat step C-4. Sufficient resistance will indicate completion of sealing and the black compaction marker will usually be exposed (Figure 16). NOTE: In some cases the compaction marker will be fully exposed when resistance is felt. In such a case the clinician should check for hemostasis before completing the procedure.
- Page 11 Fig. 18 using a sterile instrument Fig. 19 The black compaction marker is non-absorbable – it must be removed. NOTE: Make sure the suture retracts below skin level to avoid infection. NOTE: If seeping of blood occurs after placing the Angio-Seal™ Device, or after removing the tamper tube, application of gentle digital pressure (one or two fingers) at the puncture site is usually sufficient to produce hemostasis.
- Page 12 SYMBOLS Consult instructions for use Quantity Date of Manufacture STERILE R For single use only Reorder Number or Catalog Number Do not use if temperature indicator dot on package has changed from light gray to dark gray or black Manufacturer Vascular Closure Device Contents of the package...
- Page 13 +1 732 302 4900 +1 800 283 7866 PM-00370...
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