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

Model Number	VXSK0122
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	Non specific EKG/ECG Changes (1817)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that st segment elevation occurred.During an atrial fibrillation/atrial flutter procedure, a versacross access solution was selected for use.The physician performed transseptal puncture, faradrive sheath exchange to advance over left atrium was difficult because the versacross wire insulation from proximal end was frayed.Farapulse pulse field ablation was applied using farawave nav to complete pulmonary vein isolation and posterior wall isolation.An atrial tachycardia was ablated with the farawave anterior and inferior to the left inferior pulmonary vein (lipv), near the mitral valve isthmus and likely adjacent to the circumflex coronary artery.Patient's ecg did not have noticeable st segment changes after ablation delivery.Patient was atrial-paced to induce atrial tachycardia.Isoprel was infused and patient was continually paced.Isoprel infusion was increased, patient was paced, and physician noticed st segment elevation.Isuprel and pacing were terminated and a 100mcg nitroglycerine was administered through the faradrive sheath and a subsequent 100mcg were administered via iv.St segment elevation resolved after the second dose of nitroglycerine.The patient fully recovered.In the physician opinion, the contribution may have been when the pulsed field ablation was delivered near circumflex coronary artery along mitral valve isthmus.No issues or contribution from transseptal.Faradrive sheath exchange was difficult because the versacross wire insulation from proximal end was frayed.The patient was not hospitalized beyond standard of care.The complication resolved before the end of the procedure.The patient has been discharged.The device is not expected to be returned for analysis (disposed).

• 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: 23408354
• Report Number: 2124215-2025-77469
• Device Sequence Number: 21087240
• Product Code: DXF
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280401(10)36968003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0036968003
• 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: 10/06/2025
• Initial Report FDA Received Date: 10/28/2025
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 73 KG