Risk Information

AngioVac Cannula Risk Information:

Indication for Use:  The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

Contraindications:  Contraindicated for patients with severe arterial or venous vascular disease, contraindicated for removal of chronic firmly adherent intravascular material (e.g., atherosclerotic plaque, chronic pulmonary embolism) and for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred.
  • Failure to inspect could result in injury to patient or user.
  • Verify that the lumen is patent and that the cannula has not been damaged or kinked prior to use.
  • Instructions for use and manuals for the AngioVac Cannula and all related accessories and extracorporeal circulatory devices should be read prior to use and devices used as indicated.
  • Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.
  • As with all medical devices, this device and ancillary equipment are to be used by trained physicians only. Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (Seldinger) vascular access techniques.
  • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device.
  • Do not use in conjunction with a power injector.
  • Do not alter the AngioVac Cannula in any way.

Adverse Events:

  • Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: Air Embolism, Arrhythmias, Blood Loss/Blood Trauma, Death, Damage to Vessel, Device Fracture/Balloon Rupture with Distal Embolization, Distal Embolization of Thrombus, Hematoma, Hemoptysis, Hemorrhage, Local or Systemic Infections, Pleural Effusion, Pulmonary Embolism, Pulmonary Infarction, Vascular Thrombus, Venous Valve Injury, Ventricular Perforation, Vessel Spasm

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

AngioVac Circuit Risk Information:

Indications for Use:  The AngioVac Circuit is indicated for use in procedure requiring extracorporeal circulatory support for period of up to six hours.

Contraindications:  Refer to the AngioVac Cannula Directions for Use (DFU) for procedure-specific contraindications.

Warnings:

  • Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping.
  • For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
  • After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.
  • Inspect product prior to, during, and after use, to ensure that no damage to the product has occurred. Failure to inspect could result in injury to patient or user.
  • Carefully examine the circuit for leaks before and during use. Leakage may result in loss of sterility, blood loss or air embolism. If leakage is observed replace the circuit, the leaking component or tighten the leaking connection.
  • Instructions for use and manuals for all related extracorporeal circulatory devices should be read prior to use, including but not limited to the AngioVac Cannula, centrifugal pump head, control console and bubble trap.
  • As with all medical devices, this device is to be used by or under the direction of trained physicians only.
  • User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device.

Adverse Events:

  • Possible complications include those normally associated with anticoagulation and extracorporeal circulation. This product, as with all extracorporeal circulatory systems, has possible side effects, which include but are not limited to: Infections, Blood Loss/Blood Trauma, Thrombus Formation and Embolic Events.

These may occur if the instructions for use are not followed.

  • Refer to the AngioVac Cannula Directions for Use (DFU) for additional listing of potential adverse events.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

 

 

 

 

 

 

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