MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Access Solution; Catheter, Septostomy

Model Number	VXSK0124
Medical Device Problem Codes	Off-Label Use (1494); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A farawave nav catheter and versacross access solution were selected for a pulmonary vein isolation procedure to treat atrial fibrillation.Vascular access was obtained and a transseptal puncture was attempted using a versacross device advanced through a non-boston scientific (non-bsc) 13f sheath.The physician initially experienced difficulty visualizing the interatrial septum with intracardiac echocardiography (ice), and despite approximately one hour of attempts, adequate visualization and device tenting could not be confirmed.No issues were observed with the versacross rf wire or any boston scientific device.It remains unknown whether patient-specific anatomy contributed to the inability to visualize the septum.The team subsequently transitioned to transesophageal echocardiography (tee) guidance, and transseptal access was successfully obtained.It was noted that the puncture location may have been slightly anterior.Following left atrial access, mapping was performed using a non-bsc mapping catheter, and pulmonary vein isolation was initiated with the farawave nav catheter.During the first ablation application in the left superior pulmonary vein, the patient experienced a prolonged pause in heart rhythm requiring advancement of the coronary sinus catheter into the right ventricle for temporary pacing support.Ablation then continued, and all pulmonary veins were successfully treated with a total ablation time of 42 minutes.During subsequent remapping of the left atrium, the certified registered nurse anesthetist (crna) reported hypotension.Ice revealed a large pericardial effusion consistent with cardiac tamponade and cardiac perforation.Emergent pericardiocentesis was performed, successfully draining the effusion and restoring hemodynamic stability.No resistance was noted during catheter manipulation, and no device malfunctions were identified with the farawave nav catheter or versacross rf wire.The patient required hospitalization beyond the standard of care.A full recovery is expected.The patient's final discharge status and current condition were not reported.

• Brand Name: VersaCross 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 ; CA 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25654109
• Report Number: 2124215-2026-34544
• Device Sequence Number: 20299747
• Product Code: DXF
• UDI-Device Identifier: 00685447019848
• UDI-Public: (01)00685447019848(17)290218(10)39136880
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 09/14/2026

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: VXSK0124
• Device Catalogue Number: VXSK0124
• Device Lot Number: 0039136880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 06/30/2026; 08/27/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 07/21/2026; 09/14/2026
• Date Device Manufactured: 02/19/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS 13F SHEATH (ABBOTT); CORONARY SINUS GUIDE CATHETER; FARAWAVE NAV (BSC); GUIDEWIRE (MERIT); OCTARAY MAPPING CATHETER (BIOSENSE WEBSTER)
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown