Important Safety Alerts

Medical device manufacturer, Biosense Webster, has issued a medical device alert concerning its CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath [Catalog Numbers: D138501, D138502, D138503].

According to the manufacturer, .initial field experience has shown a higher than anticipated number of complaints where the haemostatic valve dislodged while introducing the dilator or devices into the VIZIGO sheath.

With a dislodged hemostatic valve, there is a potential loss of hemostasis that would be expected to result in minor bleeding. In an extremely rare circumstance, entrainment of air could lead to air embolism. The manufacturer has received reports of minor bleeding associated with this issue, but they have not received any reports of air embolism, or any other serious patient adverse events.

Users are reminded of the precautions on inserting the dilator or catheters in the medical device from Instruction For Use:

• Use best practices for inserting or retracting any device at the hemostatic valve.
• Do Not remove dilator or catheter rapidly. Damage to hemostatic valve may occur.
• Aspirate slowly, only from the sideport.
• Slowly remove or insert the dilator or other devices.
• Once the sheath is inserted into the vasculature and the dilator is removed, aspirate until steady blood return is achieved prior to flushing or infusion.
• Prior to inserting the device into the patient, pre-assemble sheath, dilator and stylet on the table. Advance the needle through the dilator and check for excessive resistance as the tip of the needle advances through the curvature of the sheath/dilator assembly.
• Before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate. After the sheath is in the left atrium of the patient, maintain a constant flow of heparinised normal saline to the sheath to minimise the risk of air emboli

If you are in possession of the affected products, please contact your supplier for necessary action.

Posted on 4 March 2021