VersaCross Connect LAAC Access Solution
Received Jul 31, 2026 · Event occurred Jul 1, 2026
Report 2124215-2026-41200 · MDR key 50098944
Device
Generic name
Dilator, Vessel, For Percutaneous Catheterization
Manufacturer
Baylis Medicale Cie IncProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Low Blood Pressure/ Hypotension
- Cardiac Tamponade
- Pericardial Effusion
Narrative
Description of Event or Problem
It was reported that pericardial effusion and cardiac tamponade, hypotension occurred. During a left atrial appendage closure (LAAC) procedure, a WATCHMAN TruSteer Access System (WAS), a 20 mm WATCHMAN FLX Pro LAA Closure and Delivery System (WDS), and a VersaCross Connect LAAC Access Solution were selected for use. While advancing the VersaCross Connect LAAC Access Solution for transseptal access, the physician experienced difficulty accessing the superior vena cava (SVC) due to challenging patient anatomy. A full dose of heparin was administered prior to the TSP. Visualization of the interatrial septum for transseptal puncture (TSP) was also limited on transesophageal echocardiography (TEE) because of an enlarged aorta. Intracardiac echocardiography (ICE) was recommended to assist with TSP guidance. The TruSteer sheath, VersaCross Connect RF wire and dilator, and ICE catheter were used while attempting to identify an optimal TSP location. During insertion of the ICE catheter, the distal end recoiled on itself due to the difficult anatomy; however, the physician was able to straighten the catheter. During attempts to perform the TSP, the patient blood pressure decreased. A pericardial sweep was performed and revealed a right-sided pericardial effusion. The activated clotting time (ACT) following the TSP was reported as 208 seconds. The physician subsequently performed a pericardiocentesis to drain the pericardial effusion. Following the pericardial drainage, the procedure was completed successfully, and the 20 mm WATCHMAN FLX Pro device was implanted. The patient was noted to be in stable condition. No device malfunction was reported.
Additional Manufacturer Narrative
Detailed product information was not provided to BSC. Good Faith efforts to obtain the information are in progress. Because the product is unknown, we are unable to provide the Unique Identifier (UDI) and other specific product information at this time. A supplemental report will be filed if the information is received.