MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cognitive Changes (2551); Pericardial Effusion (3271)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts are in progress to retrieve the device status, but it has not been obtained yet.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.
Event or Problem Description
It was reported that the patient experienced cardiac tamponade, pericardial effusion, hypotension, and reduced neurological status.During a left atrial appendage closure (laac) procedure a versacross connect laac access solution rf wire was used.When performing the transseptal puncture (tsp) multiple drop downs were required to get ideal position on the septum.During two of these attempts there was evidence that the rf wire seemed to slip into the left atrium (la) through a small opening, but no further dilation was performed since the opening was not in an ideal spot.The tsp was performed inferior and posterior before moving on to the laac, which was completed within twenty-five minutes post-tsp.A trivial pericardial effusion around the right sided chambers was noted on echocardiography at the end of the procedure, but it was not deemed a concern.When the patient was in recovery a drop in blood pressure occurred and the patient became less responsive.A pericardial tap was performed which removed more than 150cc of fluid and the patient's condition improved.The patient was hospitalized but is expected to fully recover.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; multitenant #2, street #58 zon; cartago, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 25315437
• Report Number: 2124215-2026-28452
• Device Sequence Number: 12104532
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• UDI-Public: (01)00685447019497(17)290106(10)38335537
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0107
• Device Catalogue Number: VXAK0107
• Device Lot Number: 0038335537
• 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: 05/20/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 06/18/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/22/2026; 07/13/2026
• Date Device Manufactured: 01/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown