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

Model Number	VXAK0003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/24/2025
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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
A thrombosis has occurred.The procedure was cancelled.It was reported that during a watchman left atrial appendage closure (laac) procedure, a versacross connect laac kit was selected for use.During the procedure a transeptal puncture was performed with a versacross connect and trusteer sheath.When the versacross rf wire was removed, a mobile object was noted on the tip of the coumadin ridge.It was not possible to determine whether it was a tissue fragment or a thrombus.The physician decided to keep the patient on oral anticoagulation (oac) and reschedule the procedure on a later date.There were no patient complications, and the patient was discharged the same day.The device is not expected to be returned for analysis (disposed).Half dose of heparin was given before transseptal and half was given after.Act was measured as 307 seconds.The patient was sent home same day.The physicians want to keep the patient on oac and re-image.
Additional Manufacturer Narrative
The device did not return for analysis.However, the reported allegation of thrombosis was confirmed based on the media provided.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
A thrombosis has occurred.The procedure was cancelled.It was reported that during a watchman left atrial appendage closure (laac) procedure, a versacross connect laac kit was selected for use.During the procedure a transeptal puncture was performed with a versacross connect and trusteer sheath.When the versacross rf wire was removed, a mobile object was noted on the tip of the coumadin ridge.It was not possible to determine whether it was a tissue fragment or a thrombus.The physician decided to keep the patient on oral anticoagulation (oac) and reschedule the procedure on a later date.There were no patient complications, and the patient was discharged the same day.The device is not expected to be returned for analysis (disposed).Half dose of heparin was given before transseptal and half was given after.Act was measured as 307 seconds.The patient was sent home same day.The physicians want to keep the patient on oac and re-image.

• 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: 22019067
• Report Number: 2124215-2025-30969
• Device Sequence Number: 13132471
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: (01)00685447018346
• 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,Followup
• Report Date (Section B): 06/19/2025

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: VXAK0003
• Device Catalogue Number: VXAK0003
• Device Lot Number: 0035565933
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 10/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White