MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT LAAC ACCESS SOLUTION; PERCUTANEOUS ATRIAL CATHETER KIT

Model Number	VXAK0109
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a watchman implant procedure, the versacross connect laac access solution was selected for transseptal access.During transeptal access the versacross was used as normal.It was noted that the wire was in close proximity to the aorta so it was moved more posterior to avoid.Upon buzzing across the dilator slipped and the hot wire bovied through the aorta.This resulted in an aortic perforation and a hematoma on the non coronary cusp.Heparin was reversed, and the watchman device was not implanted.The patient underwent ct imaging and was transferred to the icu for monitoring.No surgical intervention was required.The procedure was aborted, and the patient was admitted for observation with plans for reassessment the following day.The patient is expected to make a full recovery.The device is not expected to be return due to disposal.
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.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Additional Manufacturer Narrative
Detailed product information was not provided to boston scientific (bsc).Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.The reported allegations are not confirmed as the device was not returned and no media was provided.Ship history review: no sales of vxak0109 identified to washington regional medical center.Therefore, device history records review could not be performed.Labelling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described withing this complaint.No updates are required to the ifu as a result of this event.Risk review: the complaint type does not present a new or unanticipated failure type or harm.Risk is captured per the versacross connect transseptal dilator.Additional review is not required.The device has not been returned to bsc for analysis, and the information within the event description suggests that the adverse events are anticipated in nature as per the ifu as reported to bsc.Known inherent risk of device was therefore selected.
Event or Problem Description
During a watchman implant procedure, the versacross connect laac access solution was selected for transseptal access.During transeptal access the versacross was used as normal.It was noted that the wire was in close proximity to the aorta so it was moved more posterior to avoid.Upon buzzing across the dilator slipped and the hot wire bovied through the aorta.This resulted in an aortic perforation and a hematoma on the non coronary cusp.Heparin was reversed, and the watchman device was not implanted.The patient underwent ct imaging and was transferred to the icu for monitoring.No surgical intervention was required.The procedure was aborted, and the patient was admitted for observation with plans for reassessment the following day.The patient is expected to make a full recovery.The device is not expected to be return due to disposal.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: PERCUTANEOUS ATRIAL CATHETER KIT
• 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: 24497245
• Report Number: 2124215-2026-11650
• Device Sequence Number: 10638275
• Product Code: OFK
• UDI-Device Identifier: 00685447019503
• UDI-Public: (01)00685447019503
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 06/25/2026

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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 06/01/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/20/2026; 06/25/2026
• 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
• Patient Age: 70 YR
• Patient Sex: Female