MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Percutaneous atrial catheter kit

Model Number	VXAK0103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that cardiac perforation, pericardial effusion and hypotension occurred.A pulse field ablation procedure was attempted using a faradrive steerable sheath, versacross connect rf wire, and versacross connect dilator.The faradrive steerable sheath was advanced into the patient anatomy, and the intracardiac echocardiography (ice) was inserted into the right atrium without any complications.The versacross connect dilator and versacross connect rf wire were inserted into the faradrive sheath and into the right atrium.Transeptal access was gained using the versacross rf wire and the physician noticed odd looking tissue at the sight of transeptal puncture and was unable to cross the faradrive sheath and versacross dilator into the left atrium.The versacross rf wire, versacross dilator and faradrive sheath were withdrawn into the right atrium, and a second transeptal puncture was performed.Shortly after the second transseptal puncture, the patient became hypotensive and a pericardial effusion and cardiac perforation were identified.The physician performed a pericardiocentesis and the patient was extubated and hospitalized beyond the standard of care.

• Brand Name: VersaCross Connect LAAC Access Solution
• Common Device Name: Percutaneous atrial catheter kit
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50545150
• Report Number: 2124215-2026-46404
• Device Sequence Number: 18804248
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: VXAK0103
• Device Catalogue Number: VXAK0103
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female