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

Model Number	VXSK0134
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/12/2026
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, as it was unavailable by the facility.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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 that laa thrombosis occurred, which led to the cancellation of the procedure.It was reported that a versacross access solution was selected for use during an ablation procedure to treat atrial fibrillation.After completing the transseptal puncture, left atrial ice imaging identified a thrombus in the left atrium appendage, and the procedure was subsequently canceled.No patient complications were reported.The patient is expected to make a full recovery.No malfunction with the device was reported.No further information was reported.The product is not expected to be returned for analysis, as it was disposed of at the facility.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc by the facility.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.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.Device analysis: it was indicated the device was disposed of by the facility; therefore, a technical analysis of the complaint device could not be completed.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications 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.Risk review: a review of the versacross access solution risk documentation was completed and confirmed that the event of thrombosis was 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 information provided, the reported event of thrombosis is a known inherent risk of the versacross access solution device.The reported thrombosis is anticipated in nature as per the ifu as reported to boston scientific.
Event or Problem Description
It was reported that laa thrombosis occurred, which led to the cancellation of the procedure.It was reported that a versacross access solution was selected for use during an ablation procedure to treat atrial fibrillation.After completing the transseptal puncture, left atrial ice imaging identified a thrombus in the left atrium appendage, and the procedure was subsequently canceled.No patient complications were reported.The patient is expected to make a full recovery.No malfunction with the device was reported.No further information was reported.The product is not expected to be returned for analysis, as it was disposed of at the facility.

• 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: 24241553
• Report Number: 2124215-2026-05905
• Device Sequence Number: 9184113
• Product Code: DXF
• UDI-Device Identifier: 00685447019893
• UDI-Public: (01)00685447019893
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/24/2026

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: VXSK0134
• Device Catalogue Number: VXSK0134
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown