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

Model Number	VXSK0132
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced pericardial effusion (pe) and arrhythmia.During a denovo pulmonary vein isolation and ablation for persistent atrial fibrillation (afib) procedure, a versacross access solution and farawave were selected for use.The transseptal approach was guided by fluoroscopy and transesophageal echocardiogram (tee).Pre tee images were obtained demonstrating no effusion.The versacross rf wire was used with a non-boston scientific sheath and dilator.First transseptal transseptal was too anterior per physician and it was decided to restick.The second transseptal was mid-mid and was used for pulmonary vein isolation procedure.The farawave catheter was used for pulmonary vein isolation, posterior, anterior, and lateral wall ablation.A post procedure his-ventricular (hv) measurement was recorded by the farawave catheter in basket position in right atrium.An effusion check was done again after first transseptal and immediately post procedure.Patient experienced a long pause during a spontaneous conversion from afib to sinus with a slow junctional response on the anterior wall ablation.Post procedure the patient developed hypotension and a slow junctional rhythm.Transthoracic echocardiogram (tte) was performed and showed an effusion.A temporary pacemaker was implanted through the right internal jugular vein and the patient was sent to intensive care unit.The effusion was stable and there was no pericardiocentesis performed.The patient has been discharged.No malfunctions were noted.The patient did have difficult anatomy with an anterior facing fossa ovalis.Act was therapeutic.Pe was located at pericardial space around ventricular apex probably.The device is not expected to be returned for analysis (disposed).
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.

• 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 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23598285
• Report Number: 2124215-2025-84757
• Device Sequence Number: 13381419
• Product Code: DXF
• UDI-Device Identifier: 00685447019879
• UDI-Public: (01)00685447019879(17)280618(10)37158844
• 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): 11/19/2025

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: VXSK0132
• Device Catalogue Number: VXSK0132
• Device Lot Number: 0037158844
• 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: 10/30/2025
• Initial Report FDA Received Date: 11/19/2025
• Date Device Manufactured: 06/19/2025
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White