MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Access Solution; Percutaneous atrial catheter kit

Model Number	VXSK0122
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); Cardiac Perforation (2513)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that cardiac tamponade and perforation had occurred.During the pulmonary vein isolation procedure versacross access solution kit was selected for use.It has been mentioned that the access was obtained to right femoral vein and transeptal puncture was performed with access to the left atrium.About 20 seconds after transeptal puncture pressures began to rapidly decrease and cardiac perforation was noted.Pericardiocentesis was performed and patient was transferred to higher level of care for cardiac surgery.There was a tear in the left atrial appendage, and the appendage was surgically clipped.The patient was recovering in intensive care and now patient has been discharged from the hospital.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of cardiac tamponade, perforation and hypotension.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: it was indicated the device was disposed for return; therefore, a technical analysis of the complaint device could not be completed.Risk review: a risk review performed for the versacross rf wire device confirmed that the events of cardiac tamponade, perforation and hypotension are known events defined in the product risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the versacross rf wire device is acceptable.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 available information, boston scientific's investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• 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 ; +1(651)440-0979
• MDR Report Key: 50855196
• Report Number: 2124215-2026-50420
• Device Sequence Number: 18518619
• Product Code: DYB
• UDI-Device Identifier: 00685447019824
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0039104295
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 02/05/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female