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

Model Number	VXSK0101
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Pericardial Effusion (3271); Thrombosis/Thrombus (4440)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombosis and pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross access solution was selected for use.The physician was attempting to cross septum but was unsuccessful the first few times applying energy with one second constant generator setting.On the fourth attempt, the wire advanced into the left atrium (la).The physician felt that the wire crossed into the la then into pericardium.A pericardial effusion (pe) was noted.The implanter and physician immediately shifted to opening a pericardiocentesis tray and tapping the patient.The patient was sent to surgery for window and clot aspiration.The patient was hospitalized.The device is not expected to be returned for analysis (disposed).
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.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b - adverse event or product problem.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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that a thrombosis and pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross access solution was selected for use.The physician was attempting to cross septum but was unsuccessful the first few times applying energy with one second constant generator setting.On the fourth attempt, the wire advanced into the left atrium (la).The physician felt that the wire crossed into the la then into pericardium.A pericardial effusion (pe) was noted.The implanter and physician immediately shifted to opening a pericardiocentesis tray and tapping the patient.The patient was sent to surgery for window and clot aspiration.The patient was hospitalized.The device is not expected to be returned for analysis (disposed).It was further reported that the septum was aneurysmal.Patient was sent to surgery after stabilized to create a window to remove some residual clot in the pericardium.No malfunctions or contributions from versacross.The patient was later discharged.
Additional Manufacturer Narrative
Correction to the follow-up 1 mdr in block(s) common device name (d2a), in section d- suspect medical device.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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 of failure to cross could not be confirmed.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, thrombosis and additional intervention required 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: based on the available information, boston scientific has selected known inherent risk of device as cause code.The device has not been returned to bsc for analysis, and the information within the event description suggests that the event is anticipated in nature as per the ifu for the versacross access solution.
Event or Problem Description
It was reported that a thrombosis and pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross access solution was selected for use.The physician was attempting to cross septum but was unsuccessful the first few times applying energy with one second constant generator setting.On the fourth attempt, the wire advanced into the left atrium (la).The physician felt that the wire crossed into the la then into pericardium.A pericardial effusion (pe) was noted.The implanter and physician immediately shifted to opening a pericardiocentesis tray and tapping the patient.The patient was sent to surgery for window and clot aspiration.The patient was hospitalized.The device is not expected to be returned for analysis (disposed).It was further reported that the septum was aneurysmal.Patient was sent to surgery after stabilized to create a window to remove some residual clot in the pericardium.No malfunctions or contributions from versacross.The patient was later discharged.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 24316708
• Report Number: 2124215-2026-07795
• Device Sequence Number: 5676780
• Product Code: DXF
• UDI-Device Identifier: 00685447019749
• UDI-Public: (01)00685447019749
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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): 04/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXSK0101
• Device Catalogue Number: VXSK0101
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 03/24/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/25/2026; 04/13/2026
• 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: 85 YR
• Patient Sex: Male
• Patient Race: White