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

Model Number	VXSK0122
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	02/19/2026
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.A good faith effort to obtain additional information is in progress.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred.It was reported that during an atrial fibrillation procedure, a versacross access solution was selected for use.There was a baseline small effusion seen on transesophageal echocardiogram (tee).The patient had to be supported for low blood pressure all throughout the case where anesthesia had to keep increasing the pressers.After ablating the right inferior pulmonary vein (ripv), the physician checked on intracardiac echocardiography (ice) for pericardial effusion and saw it had grown substantially as compared to baseline.46 ablations had been performed.A pericardiocentesis was performed.The patient was admitted to intensive care unit and expected to fully recover.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being updated for the fields describe event or problem (b5), in section b - adverse event or product problem, and device code (f10 and h6), in sections f - user facility / importer report information and h - device manufacturers only.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 a pericardial effusion (pe) occurred.It was reported that during an atrial fibrillation procedure, a versacross access solution was selected for use.There was a baseline small effusion seen on transesophageal echocardiogram (tee).The patient had to be supported for low blood pressure all throughout the case where anesthesia had to keep increasing the pressers.After ablating the right inferior pulmonary vein (ripv), the physician checked on intracardiac echocardiography (ice) for pericardial effusion and saw it had grown substantially as compared to baseline.46 ablations had been performed.A pericardiocentesis was performed.The patient was admitted to intensive care unit and expected to fully recover.It was further reported that there was a minor setback when going transeptal as the first rf energy delivery for puncture did not send the wire through the septum.There was no difficulty noted with the ablation.The physician finished the last 2-4 ablations to complete the full workflow for pvi after the pe was noted.The physician does not believe that access solution or the ablation catheter was the cause.Act was therapeutic throughout the procedure and the patient has been discharged.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred.It was reported that during an atrial fibrillation procedure, a versacross access solution was selected for use.There was a baseline small effusion seen on transesophageal echocardiogram (tee).The patient had to be supported for low blood pressure all throughout the case where anesthesia had to keep increasing the pressers.After ablating the right inferior pulmonary vein (ripv), the physician checked on intracardiac echocardiography (ice) for pericardial effusion and saw it had grown substantially as compared to baseline.46 ablations had been performed.A pericardiocentesis was performed.The patient was admitted to intensive care unit and expected to fully recover.It was further reported that there was a minor setback when going transeptal as the first rf energy delivery for puncture did not send the wire through the septum.There was no difficulty noted with the ablation.The physician finished the last 2-4 ablations to complete the full workflow for pvi after the pe was noted.The physician does not believe that access solution or the ablation catheter was the cause.Act was therapeutic throughout the procedure and the patient has been discharged.
Additional Manufacturer Narrative
Device technical analysis it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.The reported allegation is not confirmed as there was no media provided and the device has not been returned to bsc for analysis.Device history record 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 assessment: a review of the versacross access solution risk documentation was completed and confirmed that the event of pericardial effusion and hypotension were 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 conclusion: boston scientific has assigned an investigation conclusion code of known inherent risk of device.The clinical events are anticipated in nature through residual risk communicated in the ifu for the device.From the dhr review, it is considered unlikely that defected device would leave the manufacturing as the wire undergoes 100% inspection for dome damage during manufacturing.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, STEERABLE
• 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: 24571717
• Report Number: 2124215-2026-13723
• Device Sequence Number: 20928871
• Product Code: DXF
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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: 0037859248
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 04/29/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/02/2026; 05/22/2026
• Date Device Manufactured: 09/17/2025
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 129 LB