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	05/08/2025
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.Good faith effort attempts are in progress to try and retrieve additional details regarding the reported event, but further information was unable to be obtained yet.
Event or Problem Description
It was reported a thrombosis was noted.The procedure was cancelled.During a watchman procedure indicated for bleeds, a versacross connect laac kit was selected for use.Baseline transesophageal echocardiogram (tee) was performed prior to getting access and there was no thrombus visualized in left atrial appendage (laa) or in right atrium.The versacross connect rf pigtail wire was advanced to the superior vena cava (svc) and the trusteer sheath was advanced to the right atrium.When the physician pulled the wire and sheath down to prepare for transeptal, a large thrombus was visualized which dislodged.All devices were removed.The pulmonary arteries were assessed and the clot was visualized in the right pulmonary artery.The patient remained hemodynamically stable.The physician decided to medically manage rather than removing the clot because the patient has a pfo.In the physician opinion, the patient recently had a pacemaker put in (b)(6) 2025 and the physician thinks the patient had a thrombus on the pacemaker lead in the svc which is why it was not visualized on tee.The patient is doing well.The device is not expected to be returned for analysis (disposed).The patient was fully heparinized prior.This all occurred prior to the transseptal.The doctor wanted to medically managed because the patient had a pfo.They intended on doing a t-pa treatment.Followed up with doctor a week later and said the patient was doing fine.

• 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: 22096566
• Report Number: 2124215-2025-34650
• Device Sequence Number: 8022200
• 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
• Report Date (Section B): 05/28/2025

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: VXAK0003
• Device Catalogue Number: VXAK0003
• Device Lot Number: 0035451526
• 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: 05/08/2025
• Initial Report FDA Received Date: 05/28/2025
• Date Device Manufactured: 08/05/2024
• 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
• Patient Sex: Female