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

Model Number	VXAK0103
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Positioning Problem (3009)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/22/2025
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.
Event or Problem Description
It was reported a vessel perforation occurred.During a watchman left atrial appendage occlusion (laao) procedure, a versacross connect laac kit was selected for use.Transesophageal echocardiogram (tee) imaging of the septum was challenging.Transseptal puncture location appeared to be inferior and mid ap when rf energy was delivered the wire was not seen in the left atrium and no bubbles were seen on tee.When observed on fluoroscopy and tee, the versacross wire was in the ascending aorta.Only the versacross pigtail wire was advanced at this time.The rf wire was retracted back into the right atrium.The patient was observed for about ten minutes with regularly cycling blood pressures and repeated tee imaging looking for effusion or bleeding issues surrounding the aorta.The patient did not experienced changes in pressure, heart rate, or effusion on tee.After ten minutes, the procedure continued successfully.More curve was added to the versacross dilator to allow for better positioning and visualization on tee.The transseptal puncture was successfully performed in an inferior and mid ap position, and the procedure continued without further incidence.The patient was discharged next day according to normal standard of care, and experienced no issues overnight after the procedure.The device is not expected to be returned for analysis (disposed).Maximal tenting was difficult to see before the puncture, but the versacross wire was easily visualized in the aorta after the crossing.

• 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): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22195381
• Report Number: 2124215-2025-38763
• Device Sequence Number: 9311501
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)271125(10)35807047
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0103
• Device Catalogue Number: VXAK0103
• Device Lot Number: 0035807047
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/12/2025
• Date Device Manufactured: 11/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Race: White