MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; CA

Model Number	VXAK0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/03/2025
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.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.
Event or Problem Description
It was reported that thrombosis occurred.During a watchman procedure, a versacross connect for laac was selected for use.The physician gave heparin as soon as transseptal puncture was completed with the versacross connect and watchman fxd double curve.There was no clot seen on fluoroscopy or transesophageal echocardiogram (tee).A non-boston scientific pigtail catheter was advanced through watchman sheath, contrast was injected to visualize the appendage.Once angiogram was completed, the pigtail catheter was removed and a clot was found on the tip.Activated clotting time (act) was 246 and an additional 4000 units of heparin were given.A scan was done with tee and no clot found in the appendage or left atrial appendage (laa).Nothing was seen on fluoroscopy either.The watchman device was prepped and deployed.Device pass criteria was met and physician released the device.As the physician came back to the right side of the heart a small clot was seen on the septum on the right side.Physician decided to leave it and did not give protamine.The procedure was completed successfully with no further patient complications.The patient stable, and was not hospitalized and they were discharged.No issues during transseptal puncture nor with versacross devices were reported.In the physician's opinion, the versacross did not contribute to the patient complication.The device is not expected to be returned for analysis (disposed).

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CA
• 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 ; CA 55112 ; 6514400979
• MDR Report Key: 22668165
• Report Number: 2124215-2025-52048
• Device Sequence Number: 7533630
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 07/30/2025

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: 07/03/2025
• Initial Report FDA Received Date: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White