VersaCross Connect Access Solution for Faradrive
Received Jul 30, 2026 · Event occurred Jul 8, 2026
Report 2124215-2026-40848 · MDR key 50081888
Device
Generic name
Dilator, Vessel, For Percutaneous Catheterization
Manufacturer
Baylis Medicale Cie IncProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Kidney injury
Narrative
Description of Event or Problem
It has been reported that Acute Kidney Injury (AKI) has occurred.During pulmonary vein isolation procedure VersaCross Connect Access Solution for Faradrive kit was selected for use. Acute Kidney Injury (AKI) occurred post procedure on July 13th. Patient received 80 applications of pulse field ablation for pulmonary vein isolation, Posterior Wall Isolation, CTI (Cavotricuspid Isthmus) ablation and Superior Vena Cava (SVC). No preexisting conditions were present. Intravenous fluids were given to patient. The patient was admitted for overnight stay but recovered and has been discharged. The device is not expected to be returning as it has been disposed.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental MedWatch will be filed.Detailed product information was not provided to BSC. We completed a good faith effort to obtain the information, but it was unable to be obtained. Because the product is unknown, we are unable to provide the Unique Identifier (UDI) and other specific product information.