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

Model Number	VXAK0109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/14/2026
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.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.
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman procedure, a versacross connect laac was selected for use.When the physician attempted to cross the septum, there was no visible tent seen on intracardiac echocardiography (ice).The physician was notified and decided to cross the septum.Within thirty seconds of coming on with energy, a sizeable effusion was noticed.The physician then performed a tap to drain the blood from the pericardial space.The patient was connected to a drain, stabilized and transported to the intensive care unit.The patient is expected to be discharged within a few days and is recovering well.In the physician opinion, when the physician was attempting to crossing the septum he punctured something besides the septum causing the patient to have a large pericardial effusion.The device is not expected to be returned for analysis (disposed).
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 a pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman procedure, a versacross connect laac was selected for use.When the physician attempted to cross the septum, there was no visible tent seen on intracardiac echocardiography (ice).The physician was notified and decided to cross the septum.Within thirty seconds of coming on with energy, a sizeable effusion was noticed.The physician then performed a tap to drain the blood from the pericardial space.The patient was connected to a drain, stabilized and transported to the intensive care unit.The patient is expected to be discharged within a few days and is recovering well.In the physician opinion, when the physician was attempting to crossing the septum he punctured something besides the septum causing the patient to have a large pericardial effusion.The device is not expected to be returned for analysis (disposed).It was further reported that the patient was discharged.

• Brand Name: VERSACROSS CONNECT LAAC 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: 24260368
• Report Number: 2124215-2026-06445
• Device Sequence Number: 20865937
• Product Code: DXF
• UDI-Device Identifier: 00685447019503
• UDI-Public: (01)00685447019503
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 02/23/2026

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: VXAK0109
• Device Catalogue Number: VXAK0109
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/23/2026
• 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: 82 YR
• Patient Sex: Male
• Patient Race: White