CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180 and counterclockwise = 180. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.

Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.

On 02/16/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via FedEx to customers informing them that Biosense Webster identified through a complaint investigation that a mix-up occurred during the manufacturing of two lots. The devices could potentially be shorter in length (24 1/8 inches (61.28 cm) instead of, 28 inches (71 cm). Customer are instructed/informed: If a CARTO VIZIGO" Bi-Directional Guiding Sheath, Medium Curve (Catalog Number: D-1385-02) from Lot Numbers 60000282 and 60000287 is being used in their facility, they should continue to follow the IFU. The Instructions for Use, on Page 7, instructs users to inspect all components before use, and prior to inserting the device into the patient, pre-assemble the sheath, dilator, and stylet on the table. While setting up for a procedure, if the dilator is protruding out the tip of the sheath more than 4 inches (10 cm), do not use the sheath. Destroy the device following their standard process. Please complete the Attestation of destruction form (Attachment 2) to receive a replacement and email it to: Email: [email protected] Subject: Attention: BWI Field Action Coordinator- Attestation product destruction. For questions or further assistance, contact Biosense Webster at [email protected]