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Indications, safety, and warnings

SSPC NXT Delivery Catheter – BBB-IFU-001190A in LAR 97649690

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

Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s InstContent

INTENDED PURPOSE/INDICATIONS FOR USE

The Delivery Catheter is intended for the venous introduction of pacing or defibrillation leads.

CONTRAINDICATIONS

  • Obstructed or inadequate vasculature for venous access 

WARNINGS

Carefully read all instructions prior to use of this product. Observe all warnings and precautions, failure to do so may result in complications. 

  • Do not advance Delivery Catheter against resistance without careful assessment of the cause of resistance under fluoroscopy. 

  • Do not advance a lead through the Delivery Catheter against resistance without careful assessment of the cause of resistance under fluoroscopy. 

  • Do not remove the Delivery Catheter or a lead placed through the Delivery Catheter against resistance without careful assessment of the cause of resistance under fluoroscopy. 

  • Do not use if labeling is incomplete or illegible. 

  • Do not expose the device to the MR environment. Testing has not been performed to establish safe use in this environment.

PRECAUTIONS

  • Read these instructions and consult the literature provided by the lead manufacturer prior to use. 

  • Store at room temperature. Data from the accelerated aging supports a recommended continuous storage temperature of 22°C. 

  • Based on distribution / transportation testing, the product may withstand temperature excursions between -30°C and 60°C. 

  • Do not expose to solvents. 

  • Care should be taken during the procedure to ensure that the hemostatic valve is not damaged and that the side port remains closed to reduce potential for air ingress or blood loss. 

ADVERSE EVENTS

Vessel trauma may result from the use of this device. Follow the enclosed directions carefully. Other potential adverse reaction that may result from the use of this device include but are not limited to: 

Possible complications associated with the Delivery Catheter include delay in procedure, vessel trauma, endocardial trauma, air ingress, blood loss, embolization (material, air), allergic reaction, lead dislodgement, infection, device incompatibility, incomplete therapy. 

Possible complications associated with the use of ancillary devices with the Delivery Catheter include: Air embolism, Bleeding, Bradycardia, Breakage/failure of the implant instruments, Cardiac perforation, Cardiac tamponade, Chronic nerve damage, Death, Extracardiac stimulation (muscle/nerve stimulation), Hematoma, Heart block, Hemothorax, Incisional pain, Infection including endocarditis, Lead dislodgement, Myocardial infarction, Myocardial trauma, Pericardial effusion, Pericarditis, Pleural Effusion, Pneumothorax, Stroke, Tachyarrhythmias, Thrombosis/thromboemboli, Valve damage, Venous occlusion, Venous trauma (e.g., perforation, dissection, erosion) 

Any serious incident that occurs in relation to this device should be reported to CenterPoint Systems LLC and the relevant local regulatory authority.

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