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

Model Number	VXAK0041
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); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced hypotension, a non-contractile right ventricle (rv), cardiac tamponade, and pericardial effusion.During a pulse field ablation (pfa) procedure to treat paroxysmal atrial fibrillation a versacross connect access solution for faradrive rf wire was used.The transseptal puncture (tsp) was performed, and the ablation procedure was proceeding normally, but during ablation of the posterior wall error 301 pre-pulse failure occurred eight times on the generator.Pulmonary vein isolation had been completed by the time of the error.It was noted that the catheter splines were separated during the ablation attempts.The procedure was suspended due to the generator error, and the farawave catheter was removed.After the patient was cardioverted, hypotension presented and transesophageal echocardiography (tee) and transthoracic echocardiography (tte) showed a non-contractile rv and pericardial effusion located on the posterior part of the left atrium (la).The non-contractile rv was reversed with vasoactive medications.Pericardial drainage was performed followed by emergency surgery with cardiopulmonary bypass (cpb).The patient was hospitalized and is expected to fully recover.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.When any further relevant information is obtained, a supplemental medwatch will be filed.

• Brand Name: VersaCross Connect Access Solution for FARADRIVE
• 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 ; +1(651)440-0979
• MDR Report Key: 25825818
• Report Number: 2124215-2026-37940
• Device Sequence Number: 13215158
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• UDI-Public: (01)00685447019046(17)280821(10)37323098
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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: VXAK0041
• Device Catalogue Number: VXAK0041
• Device Lot Number: 0037323098
• 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: 07/09/2026
• Supplement Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 08/22/2025
• 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; Hospitalization; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male