MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0009
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
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.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.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a cardiac perforation, pericardial effusion (pe) and cardiac tamponade occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.The patient had pacemaker leads and due to that the fellow physician was having a hard time navigating to the superior vena cava (svc) with versacross rf wire.During several attempts to cannulate the svc, an effusion in right atrial was noted on transesophageal echocardiogram (tee).Thus, a pericardiocentesis was performed, and the decision was made to take the patient for surgical repair when effusion did not resolve after.The plan was to have them clip the appendage in surgery.The patient was stable up until they were transported to surgery and they were hospitalized beyond standard of care.The patient is expected to fully recovery.The perforation was located at the right atrial (ra), prior to transseptal attempt.The left side was never accessed.The patient was not under warfarin at the time, and they were under eliquis during the procedure.The device is not expected to be returned for analysis (disposed).
Event or Problem Description
It was reported that a cardiac perforation, pericardial effusion (pe) and cardiac tamponade occurred.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.The patient had pacemaker leads and due to that the fellow physician was having a hard time navigating to the superior vena cava (svc) with versacross rf wire.During several attempts to cannulate the svc, an effusion in right atrial was noted on transesophageal echocardiogram (tee).Thus, a pericardiocentesis was performed, and the decision was made to take the patient for surgical repair when effusion did not resolve after.The plan was to have them clip the appendage in surgery.The patient was stable up until they were transported to surgery and they were hospitalized beyond standard of care.The patient is expected to fully recovery.The perforation was located at the right atrial (ra), prior to transseptal attempt.The left side was never accessed.The patient was not under warfarin at the time, and they were under eliquis during the procedure.The device is not expected to be returned for analysis (disposed).It was further reported that the wire was difficult to navigate to get around pacer leads.Rf wire was never tented and no rf was applied.Effusion was noted prior to reaching the septum for a tsp attempt.As per physician, nothing due to the system itself, just challenging anatomy and circumstances.The perforation confirmed by the surgeon on the lateral wall of the right atrium, believed to have been a result of trying to pass the wire beyond pacer leads.Act was therapeutic.The patient recovered well from surgery and has been discharged.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b - adverse event or product problem.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 not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24193451
• Report Number: 2124215-2026-04829
• Device Sequence Number: 18529227
• Product Code: DXF
• UDI-Device Identifier: 00685447010548
• UDI-Public: (01)00685447010548
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0009
• Device Catalogue Number: VXAK0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/23/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female