Vessel Closure

Indications: The Perclose™ ProStyle™ Suture-Mediated Closure and Repair (SMCR) System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access sites of patients who have undergone diagnostic or interventional catheterization procedures.

The Perclose™ ProStyle™ SMCR System is used without or, if required, with adjunctive manual compression.

For access sites in the common femoral artery using 5F to 21F sheaths.

For access sites in the common femoral vein using 5F to 24F sheaths.

For arterial and venous sheath sizes greater than 8F, at least two devices and the pre-close technique are required.

CAUTION:Federal law restricts this medical device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott.

Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.

During closure of access sites using a procedural sheath greater than 8F, it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to repair the vessel is needed.

Contraindications: There are no known contraindications to the use of this device.

Warnings: Do not use the Perclose™ ProStyle™ SMCR System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Perclose™ ProStyle™ SMCR System is intended for single use only.

Do not use the Perclose™ ProStyle™ SMCR System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral vessel.

Do not use the Perclose™ ProStyle™ SMCR System in arterial access if the puncture is through the posterior wall or if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose™ ProStyle™ SMCR System in venous access if there are multiple punctures in the same access site, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose™ ProStyle™ SMCR System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a right anterior oblique (RAO) and left anterior oblique (LAO) angiogram to adequately visualize where the sheath enters the vessel.

Precautions:

• Prior to use, inspect the Perclose™ ProStyle™ SMCR System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.
• As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose™ ProStyle™ SMCR System. Employ appropriate groin management, as per hospital protocol, post procedure, and post hospital discharge to prevent infection.
• Use a single wall puncture technique. Do not puncture the posterior wall of the vessel in arterial access.
• Do not deploy the Perclose™ ProStyle™ Device at an angle greater than approximately 45 degrees, as this may cause a cuff miss.
• There are no reaccess restrictions if previous arteriotomy / venotomy repairs were achieved with Abbott Medical SMC or SMCR systems.
• If significant blood flow is present around the Perclose™ ProStyle™ SMCR Device, do not deploy needles. Remove the device over a 0.038" (0.97 mm) (or smaller) guide wire and insert an appropriately sized introducer sheath.
• Prior to pushing the plunger to advance the needles, stabilize the device by the body to ensure the foot is apposed to the vessel wall and the device does not twist during deployment. Twisting (torquing) of the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
• Do not apply excessive force to the lever when returning the foot to its original position down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair.
• Do not advance or withdraw the Perclose™ ProStyle™ SMCR Device against resistance until the cause of that resistance has been determined. Excessive force used to advance or torque the Perclose™ ProStyle™ SMCR Device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
• If excessive resistance in advancing the Perclose™ ProStyle™ SMCR Device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guide wire and reinsert the introducer sheath or use manual compression.
• Remove the Perclose™ ProStyle™ sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.
• Care should be taken to avoid damage to the suture from handling. Avoid crushing damage due to application of surgical instruments such as clamps, forceps or needle holders.
• For catheterization procedures using a 5 – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
• For catheterization procedures using a procedural sheath > 8F, use manual compression, compression assisted devices, surgical repair, and / or other appropriate treatment methods in the event that bleeding from the femoral access site persists after the use of the Perclose™ ProStyle™ SMCR System to obtain hemostasis.
• For catheterization procedures using a procedural sheath > 8F, where the operating physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary vascular surgical intervention.

Potential Adverse Events: Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following:

• Allergic reaction or hypersensitivity to device components
• Vascular access complications which may require transfusion or vessel repair, including:
  • Anemia
  • Aneurysm
  • Arteriovenous fistula
  • Bleeding / hemorrhage / re-bleeding
  • Bruising / hematoma
  • Embolism
  • Inflammation
  • Intimal tear / dissection
  • Perforation
  • Pseudoaneurysm
  • Retroperitoneal hematoma / bleeding
  • Scar formation / calcification
  • Wound dehiscence
• Cardiac arrhythmias (including conduction disorders, atrial and ventricular arrhythmias)
  • Atrial arrhythmias
  • Ventricular arrhythmias
• Femoral artery / venous complications which may require additional intervention, including:
  • Arterial / venous stenosis
  • Arterial / venous occlusion
  • Arteriovenous fistula
  • Intimal tear / dissection
  • Ischemia distal to closure site
  • Nerve injury
  • Numbness
  • Thrombus formation
  • Vascular injury
• Peripheral ischemic conditions (including deep vein thrombosis,
• pulmonary embolism, post-procedure pulmonary embolism):
  • Deep vein thrombosis
  • Pulmonary embolism
• Infection:
  • Infection / sepsis
• Pain
• Hemodynamic instability:
  • Hypotension / hypertension
  • Vasovagal episode
• Death
• Device complications
• Device failure
• Device malfunction

Indications

The Perclose ProGlide™ SMC System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures.
The Perclose ProGlide™ SMC System is used without or, if required, with adjunctive manual compression.
For access sites in the common femoral artery using 5F to 21F sheaths.
For access sites in the common femoral vein using 5F to 24F sheaths.
For arterial and venous sheath sizes greater than 8F, at least two devices and the pre-close technique are required.

Caution

Federal law restricts this device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and / or interventional catheterization procedures and who has been trained by an authorized representative of Abbott Vascular.

Prior to use, the operator must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.

During closure of access sites using a procedural sheath greater than 8F it is recommended that a vascular surgeon or a surgeon with vascular training be available in case surgical conversion to control bleeding and to close the vessel is needed.

Contraindications

There are no known contraindications to the use of this device. Attention is drawn to the WARNINGS and PRECAUTIONS sections.

Warnings

Do not use the Perclose ProGlide™ SMC device or accessories if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The Perclose ProGlide™ SMC device and accessories are intended for single use only.

Do not use the Perclose ProGlide™ SMC System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.

Do not use the Perclose ProGlide™ SMC System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a Right Anterior Oblique (RAO) and Left Anterior Oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral artery or vein.

Do not use the Perclose ProGlide™ SMC System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a hematoma or retroperitoneal bleed.

Do not use the Perclose ProGlide™ SMC System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site. NOTE: This may require both a Right Anterior Oblique (RAO) and Left Anterior Oblique (LAO) angiogram to adequately visualize where the sheath enters the femoral artery or vein.

Precautions

1. Prior to use, inspect the Perclose ProGlide™ SMC System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.
2. As with all catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the Perclose ProGlide™ SMC System. Employ appropriate groin management, as per hospital protocol, post procedure and post hospital discharge to prevent infection.
3. Use a single wall puncture technique. Do not puncture the posterior wall of the vessel.
4. Do not deploy the Perclose ProGlide™ SMC device at an angle greater than 45 degrees, as this may cause a cuff miss.
5. There are no reaccess restrictions if previous access site repairs were achieved with Abbott Vascular SMC devices.
6. If significant blood flow is present around the Perclose ProGlide™ SMC device, do not deploy needles. Remove the Perclose ProGlide™ SMC device over a 0.038" (0.97mm) (or smaller) guidewire and insert an appropriately sized introducer sheath.
7. When pushing the plunger assembly to advance the needles, stabilize the device to ensure the device does not twist or move forward during deployment. Twisting the device could lead to needle deflection resulting in a cuff miss. Do not use excessive force or repeatedly push the plunger assembly. Excessive force on the plunger during deployment could potentially cause breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
8. Do not apply excessive force to the lever when returning the foot to its original position (marked #4) down to the body of the device. Do not attempt to remove the device without closing the lever. Excessive force on the lever of the device or attempting to remove the device without closing the lever could cause breakage of the device and / or lead to vessel trauma, which may necessitate intervention and / or surgical removal of the device and vessel repair.
9. Do not advance or withdraw the Perclose ProGlide™ SMC device against resistance until the cause of that resistance has been determined (see Section 11.3 Single SMC DEVICE PLACEMENT section). Excessive force used to advance or torque the Perclose ProGlide™ SMC device should be avoided, as this may lead to significant vessel damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and vessel repair.
10. If excessive resistance in advancing the Perclose ProGlide™ SMC device is encountered, withdraw the device over a 0.038" (0.97 mm) (or smaller) guidewire and reinsert the introducer sheath or use manual compression.
11. Remove the Perclose ProGlide™ sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.
12. During closure of access sites using a 5 – 8F procedural sheath, use manual compression in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide™ SMC device.
13. During closure of access sites using a procedural sheath > 8F, in the event that bleeding from the femoral access site persists after the use of the Perclose ProGlide™ SMC devices, the physician should assess the situation. Based on the physician assessment of the amount of bleeding use manual compression, compression assisted devices and / or a surgical repair to obtain hemostasis.
14. During closure of access sites using a procedural sheath > 8F, in those cases where the implanting physician is not a vascular surgeon, it is recommended that a vascular surgeon or a surgeon with vascular training be available during the procedure to perform any necessary surgical intervention.

Potential Adverse Events

Potential adverse events associated with use of suture mediated closure devices may include, but are not limited to, the following:

• Allergic reaction or hypersensitivity to device components
• Anemia
• Arterial stenosis / occlusion
• Arteriovenous fistula
• Bleeding / hemorrhage
• Bruising / hematoma
• Death
• Deep vein thrombosis
• Device entrapment
• Device failure / malfunction / misplacement
• Diminished pulses distal to closure site
• Embolism
• Hypotension / hypertension
• Infection / sepsis
• Inflammation
• Intimal tear / dissection
• Ischemia distal to closure site
• Nerve injury
• Numbness
• Pain
• Perforation
• Pseudoaneurysm
• Pulmonary embolism
• Retroperitoneal hematoma / bleeding
• Thrombus formation
• Vascular injury
• Vasoconstriction / vasospasm
• Vasovagal episode
• Wound dehiscence

Indications For Use

The StarClose SE™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.

The StarClose SE™ Vascular Closure System is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement.

The StarClose SE™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation in patients who have undergone interventional endovascular catheterization procedures utilizing a 5F or 6F procedural sheath.

Caution

Federal law restricts this device to sale by or on the order of a physician (or allied healthcare professionals, authorized by, or under the direction of, such physicians) who is trained in diagnostic and therapeutic catheterization procedures and who has been trained by an authorized representative of Abbott Vascular.
Prior to use, the operators must review the Instructions for Use and be familiar with the deployment techniques associated with the use of this device.

Contraindications

The StarClose SE™ Vascular Closure System is contraindicated for use in patients with known hypersensitivity to nickel-titanium.

Warnings

Do not use the StarClose SE™ Vascular Closure System if the packaging or sterile barrier has been previously opened or damaged or if the components appear to be damaged or defective.

DO NOT RESTERILIZE OR REUSE. The StarClose SE™ Vascular Closure System and accessories are intended for single use only.

Do not use the StarClose SE™ Vascular Closure System if the sterile field has been broken where bacterial contamination of the sheath or surrounding tissues may have occurred, since such a broken sterile field may result in infection.
Do not use the StarClose SE™ Vascular Closure System if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and / or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma. Perform a femoral angiogram to verify the location of the puncture site.

Do not use the StarClose SE™ Vascular Closure System if the puncture is through the posterior wall or if there are multiple punctures, since such punctures may result in a retroperitoneal hematoma.

Do not use the StarClose SE™ Vascular Closure System if the puncture site is located in the superficial femoral artery or the profunda femoris artery, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure (thrombosis of small artery lumen). Perform a femoral angiogram to verify the location of the puncture site.

Precautions

1. The StarClose SE™ Vascular Closure System should be used only by operators trained in diagnostic and interventional catheterization procedures who have been certified by an authorized representative of Abbott Vascular Inc.

2. The StarClose SE™ Vascular Closure System is provided sterile and non-pyrogenic in unopened undamaged packaging. Products are sterilized with ethylene oxide and intended for single use only. Do not resterilize. Store in a cool, dry place.

3. Prior to use, inspect the StarClose SE™ Vascular Closure System to ensure that the sterile packaging has not been damaged during shipment. Examine all components prior to use to verify proper function. Exercise care during device handling to reduce the possibility of accidental device breakage.

4. As with catheter-based procedures, infection is a possibility. Observe sterile technique at all times when using the StarClose SE™ Vascular Closure System. Employ appropriate groin management post procedure and post hospital discharge to prevent infection.

5. Use a single wall puncture technique. Do not puncture the posterior wall of the artery.

6. Do not use the StarClose SE™ Vascular Closure System to close vessels with diameters less than 5 mm.

7. Do not deploy the Clip in areas of calcified plaque.

8. The StarClose SE™ Vascular Closure System can be used ONLY with the StarClose Exchange System (included in the StarClose SE™ Vascular Closure System packaging).

9. Do not advance or withdraw the StarClose SE™ Vascular Closure Device against resistance until the cause of that resistance has been determined. Excessive force used to advance or torque the StarClose SE™ device should be avoided, as this may lead to significant vessel damage and/or breakage of the device, which may necessitate interventional and/or surgical removal of the device and vessel repair.

Adverse Events

Potential adverse events that could be associated with the use of this device include:
Major Vascular Complications • Vascular Injury Requiring Repair • Surgery • Angioplasty • Ultrasound Guided Compression • Thrombin Injection or Other Percutaneous Procedure • New Ipsilateral Lower Extremity Ischemia • Access Site-related Bleeding Requiring Transfusion • Access Site-related Infection Requiring Intravenous Antibiotics or Prolonged Hospitalization • Access Site-related Nerve Injury Requiring Intervention • Death Minor Vascular Complications • Pseudoaneurysm • Arteriovenous Fistula • Hematoma (≥ 6 cm) • Late Access Site-related Bleeding • Transient Lower Extremity Ischemia • Ipsilateral Deep Vein Thrombosis • Transient Access Site-related Nerve Injury • Access Site-related Vessel Injury • Access Site Wound-related Dehiscence • Access Site-related Bleeding Requiring ≥ 30 minutes to Re-achieve Hemostasis • Localized Access Site Infection Treated with IM or Oral Antibiotics • UADE

Prior to use, please reference the Instructions for Use at eifu.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.

Indications For Use

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. (Refer to PRECAUTIONS, SPECIAL PATIENT POPULATIONS sections).

Contraindications

None known.

Warnings

The outer pouch of the Prostar™ XL PVS System and the individual accessories provides the sterile barrier.
Do 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.
DO NOT RESTERILIZE OR REUSE. The Prostar™ XL PVS System and accessories are intended for single use only. 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.

Precautions

1. 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.

2. Observe sterile technique at all times when using the Prostar™ XL PVS System. Employ appropriate groin management, as per hospital protocol, post procedure and post hospital discharge to prevent infection.

3. Use a single wall puncture technique. Do not puncture the posterior wall of the artery.

4. Adequate knot security requires accepted surgical technique as warranted by surgical circumstances and the experience of the operator.

5. There are no reaccess restrictions if previous arteriotomy repairs were achieved with an Abbott Vascular Suture Mediated Device.

6. Do not insert the Prostar™ XL device into the femoral artery at an angle greater than 45 degrees to the longitudinal plane of the artery.

7. Do not advance or withdraw the Prostar™ XL device against resistance until the cause of that resistance has been determined (see CLINICAL PROCEDURE-Device Placement section). Excessive force used to advance or torque the Prostar™ XL device should be avoided as it may lead to significant arterial damage and / or breakage of the device, which may necessitate intervention and / or surgical removal of the device and arterial repair.

8. If excessive resistance in advancing the Prostar™ XL device is encountered, withdraw the Prostar™ XL device over a 0.038” (or smaller) guide wire and reinsert the introducer sheath or use conventional compression therapy.

9. In the event suture breakage occurs after an initial knot has been tied, care should be taken to avoid excessive force if the reintroduction of the Prostar™ XL device or introducer sheath is required. Any resistance to introduction should result in advancement of an introducer sheath small enough to be introduced without undue force.

10. If significant blood flow is evident through or around the barrel of the Prostar™ XL device, do not deploy needles. Remove the Prostar™ XL device over a 0.038” (or smaller) guide wire and insert an appropriately sized introducer sheath.

11. Remove the Prostar™ XL sheath before tightening the suture. Failure to remove the sheath prior to tightening the suture may result in detachment of the tip of the sheath.

12. Do not attempt to re-deploy Prostar™ XL needles after the needles have been “backed-down” into the sheath (refer to the TECHNIQUE FOR NEEDLE BACK-DOWN section).

13. In the event bleeding from the femoral access site persists after the use of the Prostar™ XL device and accessories, use conventional compression therapy.

Adverse Events

The following adverse events have been reported and may occur include • Device Malfunction • Device Complication • Vascular Repair • Ultrasound Guided Compression • Transfusion • Infection Requiring IV Antibiotics • Hematoma > 6 cm • AV Fistula • Nerve Injury • Pseudoaneurysm

Prior to use, please reference the Instructions for Use at eifu.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.

Indications For Use

The FemoStop™ Femoral Compression System is indicated for use in the compression of the femoral artery or vein after vessel cannulation and in ultrasound-guided compression repair of a femoral artery pseudoaneurysm.

Contraindications

• Severe peripheral vascular disease due to the risk of arterial thrombosis.
• Critical limb ischemia.
• Overlying skin necrosis and/or infection.
• Arterial injuries above or near the inguinal ligament.
• The inability to adequately compress due to e.g. coexisting very large hematomas, excessive pain or discomfort (despite anesthetics/analgesics).
• Patients not suitable for compression of their femoral artery due to leg edema, femoral nerve compression, or arterial obstruction.
• Femoral artery graft or vein graft due to the risk of damage.
• Ultrasound-guided compression repair of infected femoral pseudoaneurysms.

Warnings

• For one time use only. Do not reuse or resterilize. Do not use if the original sterile package is not intact. Inspect the system carefully prior to use to verify that all parts are present and undamaged.
• Reuse after cleaning attempts, resterilization and repackaging may result in patient/user infections, product deterioration leading to, e.g. reduced concentration of dome pressure, causing bleeding. Do not disassemble or attempt to repair the system.
• Adequate compression may not be obtained in markedly obese patients.
• Avoid releasing pressure suddenly to reduce any risk of flushing thrombotic material into the artery. Release of thrombotic material may result in embolization which could lead to patient injury.
• Do not leave the system on the patient for inappropriately long compressions, as tissue damage may occur. A brief interruption at least every three hours of pressure is recommended during long compression periods. Inappropriately long compression and/or immobilization may increase the risk for thrombosis or embolization which could lead to patient injury or death.
• If arterial/venous hemostasis is not achieved, significant bleeding may occur which could result in patient injury or death.
• While removing the sheath, ensure that the pressure applied is kept low, to avoid damage to the vessel or a “milking” effect. Allowance for slight bleeding at the site is preferred to preclude introduction of thrombus to the vessel.
• To prevent limb ischemia, do not leave artery completely blocked for more than 3 minutes. Check pedal pulse periodically to confirm whether or not flow remains in the vessels.
• To minimize the risk for arterial/venous fistula formation, venous hemostasis should be achieved prior to removal of the arterial sheath.
• Do not apply pressure to a femoral artery stent due to risk of damage.

Precautions

• The FemoStop™ Femoral Compression System should only be used for compression of the femoral artery or vein after vessel cannulation by or on the order of physicians trained in femoral artery or vein compression procedures.
• Federal (USA) law restricts this device to sale by or on the order of a physician.
• When removing the sheath for an Intra-Aortic Balloon Pump (IABP), the Instruction for Use for the IABP should be followed as appropriate.
• For successful compression, the system must be snug and secure around the patient’s hips before pressure is applied. Do not over-tighten the belt.
• For successful compression, the system must be correctly positioned throughout the procedure so that pressure is applied to the point intended.
• On very obese patients, it may be necessary to tighten the belt slightly more to enhance downward compression.
• When using the system on obese patients, fatty tissue may be displaced giving a false impression of a developing hematoma.
• Placement of the system may not be suitable on large patients, or patients with very wide hips as the belt may be too short. An abdominal strap/tape may be used to pull excessive adipose tissue away from dome.
• The target inflation pressure should be 10-20mmHg above the systolic pressure, or higher if necessary to control the bleeding. Exceeding pressures of 200mmHg may indicate the need to tighten the belt or reposition the dome.
• Careful monitoring of the dome pressure during the initial period of use is recommended, as the elastic material of the dome may stretch slightly during the first few minutes. You may notice a slight drop in pressure on the manometer. If this occurs, reinflate to initial pressure.
• Ensure that the control knob on the pump is closed when increasing the pressure and open when decreasing the pressure.
• Ensure that the pinch clamp is open when increasing or decreasing the pressure.
• Use of the FemoStop™ Femoral Compression System is not intended to replace careful monitoring of the patient’s puncture site. The patient should not be left completely unattended during the time of compression.
• The compression system is for single use only.
• Avoid exposing the pump to any liquid.
• After use, this product may be a potential biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
• The temperature range on the label represents the temperature for long-term storage.

Adverse Events

Possible adverse effects that may result from the use of this device include but are not limited to:

• tissue necrosis
• blistering of the skin/skin abrasion
• compression injuries to nerves with subsequent sensory and motor deficits
• femoral artery and/or vein thrombosis
• embolization
• bleeding or hematoma
• arterio-venous fistula or pseudoaneurysm
• acute distension or rupture of a pseudoaneurysm during compression repair

Additional warnings and precautions for ultrasound-guided compression repair of a pseudoaneurysm in the femoral artery

Warnings

• To prevent limb ischemia, do not leave artery completely blocked for more than 3 minutes.
• Use color Doppler to periodically confirm whether or not flow remains in the vessels.
• Do not leave the system on the patient for inappropriately long compressions, as tissue damage may occur.
• During long compression periods, pressure should be briefly interrupted at least every three hours. Use manual compression during this break to limit new flow into the pseudoaneurysm.
• Inappropriately long compression and/or immobilization may increase the risk for thrombosis or embolization which could lead to patient injury or death.

Precautions

• The FemoStop™ Femoral Compression System should only be used for ultrasound-guided compression repair of a pseudoaneurysm in the femoral artery, by physicians trained in the treatment of pseudoaneurysm.
• Remove any residual ultrasound gel from the skin overlying the point to be compressed as it may cause the system to slip out of position during the application of pressure.
• Exceeding pressures of 200mmHg may indicate the need to tightly secure the belt or reposition the arch.