MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Catheter, Septostomy

Model Number	VXAK0107
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Codes	Chest Pain (1776); Hematoma (1884)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient experienced a hematoma, chest pain and the procedure was cancelled.Using the versacross connect system inside of a trusteer sheath a transeptal rf puncture was made.The physician crossed into the left atrium with the versacross wire and the imaging physician stated he did not see the wire in the left superior pulmonary vein.The wire was determined to be at the back wall of the atrium and the implanting physician stated that the tactile feedback from the wire didn't feel right so he chose not to push the sheath across the septum.The imager then noticed a large hematoma forming within the wall of the left atrium, so the decision was made to abort the watchman and get a transthoracic echo with a computed tomography (ct) to follow later.There is no treatment being performed at this time.Physician ordered multi-imaging modalities for follow up today and tomorrow.Left atrium hematoma with some compression of the left atrium, chest pain.The patient was hospitalized.
Additional Manufacturer Narrative
Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress.If further information is available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient experienced a hematoma, chest pain and the procedure was cancelled.Using the versacross connect system inside of a trusteer sheath a transeptal rf puncture was made.The physician crossed into the left atrium with the versacross wire and the imaging physician stated he did not see the wire in the left superior pulmonary vein.The wire was determined to be at the back wall of the atrium and the implanting physician stated that the tactile feedback from the wire didn't feel right so he chose not to push the sheath across the septum.The imager then noticed a large hematoma forming within the wall of the left atrium, so the decision was made to abort the watchman and get a transthoracic echo with a computed tomography (ct) to follow later.There is no treatment being performed at this time.Physician ordered multi-imaging modalities for follow up today and tomorrow.Left atrium hematoma with some compression of the left atrium, chest pain.The patient was hospitalized.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of a difficult/failure to visualize device, hematoma and chest pain.The device was discarded; therefore, a technical analysis of the complaint device could not be completed.Media was provided and the hematoma was confirmed.Device history record review it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Risk review: a risk review performed for the versacross device confirmed that the event of difficult/failure to visualize device, hematoma and chest pain are known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Investigation conclusion boston scientific has assigned an investigation conclusion code of cause not established, known inherent risk of device and supporting evidence that came to this conclusion.Potential causes include incorrect rfw positioning on septum, difficult patient anatomy, insufficient imaging, or physician/scrub tech technique.Boston scientifics investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.

• 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 (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 ; +1(651)440-0979
• MDR Report Key: 25850258
• Report Number: 2124215-2026-38391
• Device Sequence Number: 5532736
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: VXAK0107
• Device Catalogue Number: VXAK0107
• Device Lot Number: 0037165419
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 07/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male