Do not puncture the posterior wall of the artery.Ĥ. Employ appropriate groin management, as per hospital protocol, post procedure and post hospital discharge to prevent infection.ģ. Observe sterile technique at all times when using the Prostar™ XL PVS System. The Prostar™ XL PVS device and accessories should only be used by physicians (or other healthcare professionals authorized by or under the direction of such physicians) after they have been trained in the use of the Prostar™ XL PVS System and accessories, e.g., participation in a Prostar™ XL PVS System training program or equivalent.Ģ.
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Do not use the Prostar™ XL PVS System if the puncture site is proximal to the inguinal ligament as this may result in a retroperitoneal hematoma. The Prostar™ XL PVS System and accessories are intended for single use only. The outer pouch of the Prostar™ XL PVS System and the individual accessories provides the sterile barrier.ĭo not use the Prostar™ PVS System or accessories if the packaging or sterile barrier have been previously opened or damaged, or if the components appear to be damaged or defective.ĭO NOT RESTERILIZE OR REUSE. (Refer to PRECAUTIONS, SPECIAL PATIENT POPULATIONS sections). The Prostar™ XL PVS System is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths.
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Top of page Prostar™ XL Percutaneous Vascular Surgical System INDICATIONS FOR USE