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

Model Number	VXAK0007
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a tissue swelling near aorta was noted.The procedure was cancelled.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.The physician was experiencing difficulty with transesophageal echocardiogram (tee) images due to patient's anatomy.During the transseptal part of the procedure, the watchman sheath and versacross connect was visualized tenting the septum in a medial position in the short axis view on tee.Decent amount of tenting on tee was seen.Echo physician confirmed the area looked better.The physician felt that it was safe to cross in this position and had the circulating nurse press the radio frequency (rf) button on the bmc rf generator.The physician was able to advance the wire without any resistance however the imaging physician was unable to visualize the wire in the left atrium.The physician decided to pull the wire back into the right atrium/inferior vena cava (ivc).It was observed a swollen part of tissue that was believed to not be there prior to transseptal.It was decided to abort the watchman procedure and to reverse the heparin that was given.The physician monitored the area for ten to fifteen minutes and did not notice any other changes to the area.The imaging physician confirmed that there was no pericardial effusion at any point during the procedure.There were no medical or surgical interventions needed.The patient was admit overnight and to do a follow up tee the following day.They could visualize the wire, but overall, the patient anatomy was very difficult to image.No other interventions required.Hemodynamics were stable the entire time.Patient was later discharged.The device is not expected to be returned for analysis (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 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 (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22913821
• Report Number: 2124215-2025-60638
• Device Sequence Number: 9055127
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/28/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0007
• Device Catalogue Number: VXAK0007
• 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: 08/11/2025
• Initial Report FDA Received Date: 08/28/2025
• 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: Male
• Patient Race: White