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

Model Number	VXSK0122
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); Needle Stick/Puncture (2462)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
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
The versacross access solution was selected for use during the pulse field ablation procedure to treat atrial fibrillation (a fib) and atrial flutter.It was reported that during the transeptal puncture, the aorta was punctured and the versacross wire was visualized in the aorta on ice.The physician continually viewed ice images and determined there was a small area of bleeding back from the aorta to the right atrium, but no aortic hematoma developed.The sheath and dilator were never advanced and therefore only the wire went into the aorta.At this point, the physician had the heparin infusion stopped and gave the patient protamine.The rf application through a non-bsc device was delivered at 12:05 and the wire was pulled out of the aorta at 12:20.The patient remained stable and was monitored for an hour prior to ending the procedure and closing the groin access site.The patient was set to stay overnight and was ordered a limited echogram.The patient remained stable throughout the monitoring period and the physician plans to bring the patient back at a later date to complete the ablation procedure.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) h6.
Event or Problem Description
The versacross access solution was selected for use during the pulse field ablation procedure to treat atrial fibrillation (a fib) and atrial flutter.It was reported that during the transeptal puncture, the aorta was punctured and the versacross wire was visualized in the aorta on ice.The physician continually viewed ice images and determined there was a small area of bleeding back from the aorta to the right atrium, but no aortic hematoma developed.The sheath and dilator were never advanced and therefore only the wire went into the aorta.At this point, the physician had the heparin infusion stopped and gave the patient protamine.The rf application through a non-bsc device was delivered at 12:05 and the wire was pulled out of the aorta at 12:20.The patient remained stable and was monitored for an hour prior to ending the procedure and closing the groin access site.The patient was set to stay overnight and was ordered a limited echogram.The patient remained stable throughout the monitoring period and the physician plans to bring the patient back at a later date to complete the ablation procedure.The device has been returned for analysis.
Event or Problem Description
The versacross access solution was selected for use during the pulse field ablation procedure to treat atrial fibrillation (a fib) and atrial flutter.It was reported that during the transeptal puncture, the aorta was punctured and the versacross wire was visualized in the aorta on ice.The physician continually viewed ice images and determined there was a small area of bleeding back from the aorta to the right atrium, but no aortic hematoma developed.The sheath and dilator were never advanced and therefore only the wire went into the aorta.At this point, the physician had the heparin infusion stopped and gave the patient protamine.The rf application through a rf wire was delivered at 12:05 and the wire was pulled out of the aorta at 12:20.The patient remained stable and was monitored for an hour prior to ending the procedure and closing the groin access site.The patient was set to stay overnight and was ordered a limited echogram.The patient remained stable throughout the monitoring period and the physician plans to bring the patient back at a later date to complete the ablation procedure.The device has been returned for analysis.** correction on the complaint summary "the rf application was delivered at 12:05 (.)".
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) b5.Investigation summary: with all the available information, boston scientific is unable to confirm the reported clinical observation of vessel perforation and hemorrhage.However, it was determined that the vessel perforation and hemorrhage is a known inherent risk of use of this device.During return device analysis, evidence of usage as charring was observed at the distal tip of the device.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: wire was observed visually and under microscope for a more detailed look.Wire was inspected of kinks and none were found.Evidence of usage as charring was observed at the distal tip of the rf -wire.Risk assessment: upon review of the complaint, the information provided does not indicate a new hazardous situation and there is no new trending information to suggest a change in the probability of the failure mode occurring.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.Investigation conclusion: based on the information provided, the reported event of cardiac tamponade is a known inherent risk of the versacross access solution device.Cardiac tamponade is an expected procedural complication addressed within the ifu for the versacross access solution device.There were no allegations of a quality or manufacturing deficiency leading to the adverse event as reported to bsc.During device testing, images of the investigation of the returned product confirm the usage of the rf wire, but it cannot be concluded with certainty what the root cause of this event was.

• Brand Name: VERSACROSS 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; 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: 23879424
• Report Number: 2124215-2025-92688
• Device Sequence Number: 4706354
• Product Code: OFK
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280618(10)37517260
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0037517260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/09/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/14/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male