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

Model Number	VXAK0001
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Fistula (1862); Perforation of Vessels (2135)
Date of Event	03/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation (disposed).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
A fissure and fistula occurred.It was reported that versacross connect laac access solution was selected for use during a watchman procedure.During transseptal access, the septum was crossed in low anterior position.The versacross wire initially encountered the resistance, difficult to advance felt like stuck and was reposition without further issue.The sheath and dilator were then advanced successfully completed.Post procedure imaging tee identified a small jet from aortic root into the left atrium, consistent with fissure and fistula.The patient remained stable with no hemodynamic complications and follow up was planned.Patient was reported to be stable with plans for a six week to recheck.The procedure was completed with original device.The patient planned was to be discharged on (b)(6) 2026.

• 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: 24916882
• Report Number: 2124215-2026-21070
• Device Sequence Number: 21288071
• Product Code: DXF
• UDI-Device Identifier: 00685447018339
• UDI-Public: (01)00685447018339
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/19/2026

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: VXAK0001
• Device Catalogue Number: VXAK0001
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female