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

Model Number	VXSK0134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Tachycardia (2095); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced cardiac tamponade, tachycardia, hypotension, intermittent chest pain, and nausea.After a concomitant pulse field ablation (pfa) and left atrial appendage closure (laac) procedure a versacross rf wire was used.The procedure was completed and the patient was moved to holding for recovery, but about two hours later the patient became tachycardic, hypotensive, and pale with nausea and intermittent chest pain.A transesophageal echocardiogram (tee) was performed, and a large effusion was found.The patient was brought to the lab for emergent pericardiocentesis and drain placement which removed 1l of dark red blood from the pericardial space.The patient was admitted to the cardiovascular intensive care united (cvicu) for additional monitoring.The patient is expected to fully recover.
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.
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.Correction to the initial mdr in block h6 patient codes.
Event or Problem Description
It was reported that the patient experienced cardiac tamponade, tachycardia, hypotension, intermittent chest pain, and nausea.After a concomitant pulse field ablation (pfa) and left atrial appendage closure (laac) procedure a versacross rf wire was used.The procedure was completed and the patient was moved to holding for recovery, but about two hours later the patient became tachycardic, hypotensive, and pale with nausea and intermittent chest pain.A transesophageal echocardiogram (tee) was performed, and a large effusion was found.The patient was brought to the lab for emergent pericardiocentesis and drain placement which removed 1l of dark red blood from the pericardial space.The patient was admitted to the cardiovascular intensive care united (cvicu) for additional monitoring.The patient is expected to fully recover.
Event or Problem Description
It was reported that the patient experienced cardiac tamponade, tachycardia, hypotension, intermittent chest pain, and nausea.After a concomitant pulse field ablation (pfa) and left atrial appendage closure (laac) procedure a versacross rf wire was used.The procedure was completed and the patient was moved to holding for recovery, but about two hours later the patient became tachycardic, hypotensive, and pale with nausea and intermittent chest pain.A transesophageal echocardiogram (tee) was performed, and a large effusion was found.The patient was brought to the lab for emergent pericardiocentesis and drain placement which removed 1l of dark red blood from the pericardial space.The patient was admitted to the cardiovascular intensive care united (cvicu) for additional monitoring.The patient is expected to fully recover.It was further reported that the activated clotting times (acts) taken during the procedure were 286 and 337 seconds, and the patient fully recovered from the complications.
Additional Manufacturer Narrative
Investigation summary: based on the available information, although no product has been returned due to disposal, we have determined that the cardiac tamponade, pericardial effusion, tachycardia, hypotension, intermittent chest pain, and nausea are known inherent risks with use of this product.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 of; therefore, a technical analysis of the complaint device could not be completed.Labeling review: review of the instructions for use confirmed that cardiac tamponade, pericardial effusion, tachycardia, hypotension, and intermittent chest pain are addressed as a potential procedural complication when using the versacross access solution.It was most likely that the nausea was a downstream consequence of one or more of the other harms.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 risk review performed for the versacross access solution device confirmed that the event of cardiac tamponade, pericardial effusion, tachycardia, hypotension, and intermittent chest pain, is a known event defined in the product's risk management documentation.It was most likely that the nausea was a downstream consequence of one or more of the other harms.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 access solution device is acceptable.Investigation conclusion: based on the information provided, the reported event of cardiac tamponade, pericardial effusion, tachycardia, hypotension, intermittent chest pain, and nausea is a known inherent risk of versacross access solution.As stated by the instructions for use, "adverse events that may occur while using the versacross access solution include: arrythmias, cardiac tamponade, hypotension, pain, pericardial effusion." there were no indications that the device was used outside the bounds of labeled/indicated use or evidence of a product performance related issue.Correction to the initial mdr in block h6 patient codes.

• 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: 24637874
• Report Number: 2124215-2026-15157
• Device Sequence Number: 9786496
• Product Code: DXF
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2026

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: VXSK0134
• Device Catalogue Number: VXSK0134
• Device Lot Number: 0038174800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/22/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/20/2026; 06/12/2026
• Date Device Manufactured: 10/06/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 147 LB