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

Model Number	VXAK0103
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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.
Event or Problem Description
The procedure was cancelled.During a watchman procedure, a versacross connect laac was selected for use.The physician performed transseptal puncture (tsp) and the rf wire advanced to left atrium (la).The wire was then visualized in the aorta on intracardiac echocardiography (ice).The wire was withdrawn back to the right side.Patient remained hemodynamically stable and no complications transpired.A redo tsp was performed.The case ultimately was aborted because they could not cross the ice catheter from the right side of the heart to the left side.Physician wanted to abort to prioritize patient safety.The device is not expected to be returned for analysis (disposed).
Event or Problem Description
The procedure was cancelled.During a watchman procedure, a versacross connect laac was selected for use.The physician performed transseptal puncture (tsp) and the rf wire advanced to left atrium (la).The wire was then visualized in the aorta on intracardiac echocardiography (ice).The wire was withdrawn back to the right side.Patient remained hemodynamically stable and no complications transpired.A redo tsp was performed.The case ultimately was aborted because they could not cross the ice catheter from the right side of the heart to the left side.Physician wanted to abort to prioritize patient safety.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Correction to the initial, mdr in block(s) b.Adverse event/product problem b1, h.Device manufacturers only (type of reportable event h1 and patient codes h6).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.
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.Correction to the follow up 1 mdr in block(s) device codes (f10 and h11), 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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available because.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
The procedure was cancelled.During a watchman procedure, a versacross connect laac was selected for use.The physician performed transseptal puncture (tsp) and the rf wire advanced to left atrium (la).The wire was then visualized in the aorta on intracardiac echocardiography (ice).The wire was withdrawn back to the right side.Patient remained hemodynamically stable and no complications transpired.A redo tsp was performed.The case ultimately was aborted because they could not cross the ice catheter from the right side of the heart to the left side.Physician wanted to abort to prioritize patient safety.The device is not expected to be returned for analysis (disposed).It was further reported that the procedure was cancelled because they had difficulty getting ice across and because the physician was already concerned about the transeptal he made the decision to abort the case.Patient has been 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: 23696460
• Report Number: 2124215-2025-88459
• Device Sequence Number: 10288784
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/22/2025

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: VXAK0103
• Device Catalogue Number: VXAK0103
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 12/08/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/10/2025; 12/22/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male