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INDICATIONS, SAFETY, AND WARNINGS SURGICAL REVASCULARIZATION PRODUCTS

INDICATIONS, SAFETY, AND WARNINGS FOR SURGICAL REVASCULARIZATION PRODUCTS

AccuMist Blower/Mister

Indications

  • This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means for improved visibility.

Contraindications

  • This device is not intended for use except as indicated above. Do not use where the effects of a CO2/medical air stream or irrigation mist are contraindicated.

Warnings

  • DO NOT USE OXYGEN WITH THIS DEVICE.
  • Use caution when moving the tip of the device near the wound or surgical site. DO NOT ALLOW TIP TO CONTACT TISSUE.

Precautions

  • To release compressed CO2/medical air in a controlled fashion, point tip of device away from the wound or surgical site before turning device on. This device is designed and intended for single-use only. DO NOT RESTERILIZE OR REUSE.

Adverse Effects

  • None known

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ClearView Blower/Mister

Indications

  • This device is intended for use during procedures when a wound or surgical site must be cleared by non-contact means to improve visibility at the site.

Contraindications

  • This device is not intended for use except as indicated above.
  • Do not use where the effects of an air stream or irrigation mist are contraindicated.

Warnings

  • Do not use oxygen with this device.
  • Do not exceed inlet pressure of 60 psi (414 kPa).
  • Use caution when moving the tip of the device closer than 3 cm (1.18 in) to the surgical site. Do not allow the tip to contact tissue.

Precautions

  • Proper surgical procedures are necessarily the responsibility of the medical profession. The described procedure is furnished for information purposes only. Each surgeon must, of course, evaluate the appropriateness of the procedure based on their own medical training and experience, and the type of surgical procedure.
  • Use only PVC tubing to connect the airline to the device.
  • The shunt, tether, and tag should remain intact. Do not separate the components.
  • Release compressed CO2/medical air in a controlled fashion, by pointing the tip of device away from the wound or surgical site before turning the device on.
  • This device was designed for single patient use only. Do not reuse, reprocess, or re-sterilize this product. Reuse, reprocessing, or re-sterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
  • Applicable where phthalates are identified on the product label: Due to the presence of phthalates in the product, the clinician must weigh the medical benefits of product use against the drawbacks of phthalate exposure for male children and pregnant or nursing women.

Adverse Effects

  • None known

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ClearView Intracoronary Shunt

Indications

  • These shunts are intended for use to shunt blood by the arteriotomy anastomosis site while the surgeon is making the anastomosis.

Contraindications

  • These shunts are not intended for use except as indicated above.

Warnings

  • Take care not to:
    • Damage or scratch the shunt prior to insertion into the coronary artery.
    • Damage the intima of the coronary artery during product use.
    • Attempt to force the shunt’s tips past any vessel obstructions.
  • In some cases, shunts may not be detectable by x-ray due to the variances in anatomical densities and x-ray techniques. Modifying the x-ray angle or distance may aid in detection.

Precautions

  • The shunt is not an implantable device and may only be used temporarily as described in the “Indications” above.
  • Check for any possible obstructions in the shunt's internal lumen before placing the shunt in the artery.
  • The shunt, tether, and tag should remain intact. Do not separate the components.
  • Note: Proper surgical procedures and techniques are necessarily the responsibility of the medical professional. The described procedure is furnished for informational purposes only. Surgeons must, of course, evaluate the appropriateness of the procedure based on their own medical training and experience and the type of surgical procedure.
  • Take care not to damage the shunt or ensnare the tether with the cardiovascular needle or suture. Remove the shunt from the vessel prior to completion of the anastomosis.
  • These shunts are designed and intended for single use only: DO NOT REUSE.

Adverse Effects

  • None known

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OctoBase Retractor Rack

Indications

  • The OctoBase retractor rack is intended to provide surgical access by retraction of soft and bony tissue.

Precautions

  • Proper surgical procedures and techniques are the responsibility of the medical professional. Surgeons must evaluate the appropriateness of any procedure based on their own medical training and experience.

Adverse Effects

  • None known

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OctoBase Suture Holding Inserts

Indications

  • The OctoBase suture holding inserts are indicated for use in securing deep pericardial sutures during coronary artery bypass procedures.
  • Additionally, the inserts are designed to secure (retractor arm) OctoBase blade sets being used for the procedure.

Contraindications

  • The safety and performance of OctoBase suture holding inserts have not been evaluated in retractor systems other than the OctoBase retractor rack. Use of the OctoBase suture holding inserts with other retractor systems is not recommended.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • Proper surgical procedures and techniques are necessarily the responsibility of the medical profession.
  • Each surgeon must evaluate the appropriateness of any procedure based on their own medical training and experience, and the type of surgical procedure.

Adverse Effects

  • None known

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Octopus 4 and Octopus 4.3 Tissue Stabilizers

Indications

  • This product is intended to stabilize and minimize the motion of selected areas of the beating heart during cardiac surgery.

Contraindications

  • This product is not intended for use except as indicated above. Do not position the tissue stabilizers over a coronary artery, newly infarcted or aneurysmal heart tissue.

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology and surgical techniques.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • The directions for use are furnished for information purposes only.
  • The product is designed and intended for single use only: DO NOT RESTERILIZE OR REUSE.
  • The initial spacing between the right and left tissue stabilizers is important for optimal performance. The initial spacing between the tissue stabilizers will affect stabilization and tension on the tissue and should be chosen at the surgeon’s discretion.
  • Canister must be oriented in a vertical position.
  • Do not fill past full line on canister.
  • Do not exceed (-)400 mm Hg of suction.

Adverse Effects

  • None known

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Octopus Evolution Tissue Stabilizer

Indications

  • This product is intended to stabilize and minimize the motion of selected areas of the beating heart during cardiac surgery.

Contraindications

  • This product is not intended for use except as indicated above. Do not position the tissue stabilizers over a coronary artery or newly infarcted or aneurysmal heart tissue.

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology, and surgical techniques.
  • This product is not intended for use as a heart positioner.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • The directions for use are furnished for information purposes only.
  • The product is designed and intended for single use only: DO NOT RESTERILIZE OR REUSE.
  • The initial spacing between the right and left tissue stabilizers is important for optimal performance. The initial spacing between the tissue stabilizers will affect stabilization and tension on the tissue and should be chosen at the surgeon’s discretion.
  • Canister must be oriented in a vertical position.
  • Do not fill past the full line on canister.
  • Do not exceed (-)400 mm Hg of suction.

Adverse Effects

  • None known

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Octopus Evolution AS Tissue Stabilizer

Indications

  • This product is intended to stabilize and minimize the motion of selected areas of the beating heart during cardiac surgery.

Contraindications

  • This product is not intended for use except as indicated above. Do not position the tissue stabilizers over a coronary artery or newly infarcted or aneurysmal heart tissue.

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology, and surgical techniques.
  • This product is not intended for use as a heart positioner.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • The instructions for use are furnished for information purposes only.
  • This device was designed for single patient use only. Do not reuse, reprocess or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness or death.
  • The initial spacing between the right and left tissue stabilizers is important for optimal performance. The initial spacing between the tissue stabilizers will affect stabilization and tension on the tissue and should be chosen at the surgeon's discretion.
  • Canister must be oriented in a vertical position.
  • Do not fill past the maximum capacity line on canister.
  • Do not exceed (-)400 mm Hg of suction.

Adverse Effects

  • None known

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Octopus Nuvo Tissue Stabilizer

Indications

  • The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery (MICS) procedures under direct visualization through a thoracotomy.

Contraindications

  • This product is not intended for use except as indicated above. Do not position the tissue stabilizer over a coronary artery, aneurysm, or newly infarcted heart tissue.

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology, and surgical techniques. This product is not intended for use as a heart positioner.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • The instructions for use are furnished for information purposes only. Canister must be oriented in a vertical position.
    • Do not exceed (–)400 mm Hg of suction.
    • Do not fill past full line on the canister.
    • Do not use product beyond its labeled shelf life.
  • This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device which could result in patient injury, illness, or death.

Adverse Effects

  • None known

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Octopus Retractor Adapter

Indications

  • This adapter is intended to provide for the secure attachment of an Octopus tissue stabilizer to a Medtronic ThoraTrak retractor or Ankeney sternal retractor arm. The adapter is fitted and tightened to the retractor arm and an Octopus tissue stabilizer is then securely clamped onto the adapter-mounting platform.

Contraindications

  • This device is not intended for use except as indicated above.

Warnings

  • The Octopus retractor adapter is provided nonsterile and must be appropriately cleaned, lubricated, and sterilized prior to each use.

Precautions

  • Proper surgical procedures and techniques are the responsibility of the medical professional. Surgeons must evaluate the appropriateness of any procedure based on their own medical training and experience.

Adverse Effects

  • None known

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Starfish Evo Heart Positioner

Indications

  • This product is intended for use during coronary artery bypass grafting operations. The intended function of this product is for positioning the heart.

Contraindications

  • This product is not intended for use except as indicated above. Do not attach device to:
    • Newly infarcted tissue
    • Aneurysmal tissue
    • Directly over a coronary artery
    • Fragile tissue

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology, and surgical techniques.
  • The Starfish Evo heart positioner is to be used only on the apex of the heart and on the left ventricle immediately proximal to the apex. 
  • Do not use on atrial tissue or on the right ventricle. 
  • Always support the heart when repositioning the heart. 

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
    • The directions for use are furnished for information purposes only.
    • Avoid placing the device directly over a deep sulcus in the epicardial fat as this may disrupt the vacuum seal and lead to a loss of heart capture.
    • This device was designed for single patient use only. Do not reuse, reprocess, or resterilize any component of this system. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
    • Canister must be oriented in a vertical position.
    • Do not exceed (-)400 mm Hg of suction.
    • Do not use this device as a suction source to remove blood from the operative field.
    • Do not fill past the maximum capacity line on canister.

Adverse Effects

  • None known

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Starfish NS Heart Positioner

Indications

  • The Starfish NS Heart Positioner is intended to enable manipulation of the beating heart in cardiac surgery procedures that utilize a thoracotomy of at least 4 cm for access.

Contraindications

  • This product is not intended for use except as indicated above. Do not attach device to:
    • Newly infarcted tissue
    • Aneurysmal tissue
    • Directly over a coronary artery
    • Fragile tissue

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology and surgical techniques.
  • The Starfish NS heart positioner is to be used only on the apex and on the left ventricle immediately lateral to the apex.
  • Do not use on atrial tissue or on the right ventricle.
  • Do not attempt to insert shaft in thoracic cavity without tunneling tip attached.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • The directions for use are furnished for information purposes only.
  • Avoid placing the device directly over a deep sulcus in the epicardial fat as this may disrupt the vacuum seal and lead to a loss of heart capture.
  • The product is designed and intended for single use only. DO NOT RESTERILIZE OR REUSE.
  • Canister must be oriented in a vertical position.
  • Do not exceed (-) 400 mm Hg of suction.
  • Do not use this device as a suction source to remove blood from the operative field.
  • Do not fill past full line on the canister.

Adverse Effects

  • None known

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ThoraTrak MICS Retractor System

Indications

  • The ThoraTrak minimally invasive cardiac surgery (MICS) retractor system is intended to provide surgical access for minimally invasive cardiothoracic procedures, including minimally invasive coronary artery bypass grafting (CABG) surgery and LIMA harvest, by retraction of soft and bony tissue.

Precautions

  • Proper surgical procedures and techniques are the responsibility of the medical professional. Surgeons must evaluate the appropriateness of any procedure based on their own medical training and experience.

Adverse Effects

  • None known

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Urchin Heart Positioner

Indications

  • This product is intended for use during coronary artery bypass grafting operations. The intended function of this product is for positioning the heart.

Contraindications

  • This product is not intended for use except as indicated above.
  • Do not attach device to:
    • Newly infarcted tissue
    • Aneurysmal tissue
    • Directly over a coronary artery
    • Fragile tissue

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology and surgical techniques.
  • The Urchin heart positioner is to be used only on the apex and on the left ventricle immediately proximal to the apex. Do not use on atrial tissue or on the right ventricle. Always support the heart when re-positioning the heart.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • The directions for use are furnished for information purposes only. Avoid placing the device directly over a deep sulcus in the epicardial fat as this may disrupt the vacuum seal and lead to a loss of heart capture.
  • The product is designed and intended for single use only: DO NOT RESTERILIZE OR REUSE.
  • Canister must be oriented in a vertical position. Do not exceed (-)250 mm Hg of suction.
  • Do not use this device as a suction source to remove blood from the operative field.
  • Do not fill past full line on canister.

Adverse Effects

  • None known

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Urchin Evo Heart Positioner

Indications

  • This product is intended for use during coronary artery bypass grafting operations. The intended function of this product is for positioning the heart.

Contraindications

  • This product is not intended for use except as indicated above. Do not attach device to:
    • Newly infarcted tissue
    • Aneurysmal tissue
    • Directly over a coronary artery
    • Fragile tissue

Warnings

  • Patient and procedure selection is the responsibility of the medical professional and the outcome is dependent on many variables, including patient anatomy, pathology, and surgical techniques. 
  • The Urchin Evo heart positioner is to be used only on the apex of the heart and on the left ventricle immediately proximal to the apex. Do not use on atrial tissue or on the right ventricle. Always support the heart when repositioning the heart.

Precautions

  • Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
  • The instructions for use are furnished for information purposes only.
  • Avoid placing the device directly over a deep sulcus in the epicardial fat as this may disrupt the vacuum seal and lead to a loss of heart capture.
  • This device was designed for single patient use only. Do not reuse, reprocess, or resterilize any component of the system. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
  • Canister must be oriented in a vertical position.
  • Do not exceed (-)250 mm Hg of suction.
  • Do not use this device as a suction source to remove blood from the operative field.
  • Do not fill past the Maximum Capacity line on canister.

Adverse Effects

  • None known

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