MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS STEERABLE ACCESS SOLUTION; PERCUTANEOUS ATRIAL CATHETER KIT

Model Number	VSTK0124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Cardiac Perforation (2513)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an atrial fibrillation ablation a rf wire was selected for use.It is believed that the transeptal wire perforated in or around the laa during exchange.A pericardial tap was performed to pull blood from the space and stabilize the patient.The procedure was cancelled at this time and the patient is expected to fully recover.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an atrial fibrillation ablation a rf wire was selected for use.It is believed that the transeptal wire perforated in or around the laa during exchange.A pericardial tap was performed to pull blood from the space and stabilize the patient.The procedure was cancelled at this time and the patient is expected to fully recover.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an atrial fibrillation ablation a rf wire was selected for use.It is believed that the transeptal wire perforated in or around the laa during exchange.A pericardial tap was performed to pull blood from the space and stabilize the patient.The procedure was cancelled at this time and the patient is expected to fully recover.
Additional Manufacturer Narrative
Investigation summary: it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.Device history review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the rf wire's risk documentation was completed and confirmed that the event of perforation was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation summary: boston scientific has assigned an investigation conclusion code of known inherent risk as a perforation was listed as a potential complication in the device's instructions.

• Brand Name: VERSACROSS STEERABLE ACCESS SOLUTION
• Common Device Name: PERCUTANEOUS ATRIAL CATHETER KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24935261
• Report Number: 2124215-2026-21434
• Device Sequence Number: 14806888
• Product Code: OFK
• UDI-Device Identifier: 00685447019732
• UDI-Public: (01)00685447019732(17)280718(10)37264598
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 06/22/2026

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: VSTK0124
• Device Catalogue Number: VSTK0124
• Device Lot Number: 0037264598
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 04/27/2026; 05/28/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/11/2026; 06/22/2026
• Date Device Manufactured: 07/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown