The Abbott Pacing Lead 5F Balloon Tip is intended for use by appropriately trained healthcare professionals during cardiac pacing and related interventional procedures. The device should be selected and used according to the patient's clinical condition, the intended procedure, and the official product instructions for use (IFU).
The pacing lead should be inspected before use to ensure that the packaging and device are intact and that there are no visible signs of damage, deformation or other abnormalities.
Use the pacing lead only for its intended clinical application and with compatible interventional equipment. Carefully follow the instructions provided by the device manufacturer for preparation, introduction, advancement, positioning and removal.
Warning for
Abbott Pacing Lead 5F Balloon Tip
Pacing Lead
This device is intended for single use only. Do not reuse or resterilize the device unless specifically permitted by the manufacturer's official instructions for use. Reuse or resterilization may compromise device performance and may increase the risk of infection, device damage or other complications.
Before use, carefully inspect the pacing lead and its packaging. Do not use the device if the package is damaged, opened or compromised, or if the device shows any visible defect, deformation or damage.
The pacing lead should be manipulated under appropriate clinical and imaging guidance, as applicable to the procedure, and with suitable precautions. Advancement or withdrawal should be performed carefully to minimize the potential for tissue injury or device damage.
If resistance is encountered during advancement, positioning or withdrawal of the pacing lead, determine the cause of the resistance before proceeding. Do not forcefully advance, withdraw or manipulate the device against significant resistance, as this may result in tissue injury or damage to the device.
Avoid excessive bending, kinking or inappropriate manipulation of the pacing lead. Do not use the device if the shaft, distal portion or balloon-tip area becomes visibly damaged, deformed or compromised during the procedure.
When using the pacing lead with other interventional or cardiac devices, ensure compatibility and follow the instructions and precautions provided for each device. Improper device combination or manipulation may result in device malfunction or procedural complications.
Care should be taken when advancing or withdrawing the pacing lead through compatible catheters, introducers or other interventional devices to minimize the risk of entanglement, damage or separation.
The Abbott Pacing Lead 5F Balloon Tip is supplied as a sterile medical device. Follow the manufacturer's storage, handling and preparation requirements before use.
Potential complications associated with cardiac pacing and interventional catheter procedures may include, but are not limited to, vessel or tissue injury, bleeding, thrombosis, embolization, infection, arrhythmia and other procedure-related complications. Appropriate clinical judgment should be exercised by the treating physician.
For complete indications, contraindications, warnings, precautions and detailed instructions for use, healthcare professionals should refer to the current official Abbott product documentation applicable to the specific product and market.
