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

Model Number	VXAK0103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage closure (laac) procedure was being performed.A versacross connect laac access solution kit was used with a watchman trusteer access system (was).A full dose of heparin was administered in partial doses after femoral access and before transseptal puncture and then seconds after the puncture was completed.First activated clotting time (act), taken about 15 minutes after the first partial dose, was 233.Second act, taken after the second partial dose, was 311.Radiofrequency (rf) energy was applied once for crossing.Once across the atrial septum with the trusteer and the versacross connect, a clot was noted on the versacross rf wire.The thrombus was flopping but did not break away and become mobile.The wire, sheath and dilator were removed from the patient, and everything was flushed.The procedure was completed as planned.No patient complications were reported.The patient is stable and was discharged the morning after the procedure.A transesophageal echocardiogram (tee) was used to complete the procedure.
Event or Problem Description
It was reported that thrombosis occurred.A left atrial appendage closure (laac) procedure was being performed.A versacross connect laac access solution kit was used with a watchman trusteer access system (was).A full dose of heparin was administered in partial doses after femoral access and before transseptal puncture and then seconds after the puncture was completed.First activated clotting time (act), taken about 15 minutes after the first partial dose, was 233.Second act, taken after the second partial dose, was 311.Radiofrequency (rf) energy was applied once for crossing.Once across the atrial septum with the trusteer and the versacross connect, a clot was noted on the versacross rf wire.The thrombus was flopping but did not break away and become mobile.The wire, sheath and dilator were removed from the patient, and everything was flushed.The procedure was completed as planned.No patient complications were reported.The patient is stable and was discharged the morning after the procedure.A transesophageal echocardiogram (tee) was used to complete the procedure.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of a thrombosis.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.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 thrombosis is a 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 no problem detected and supporting evidence that came to this conclusion.It was determined that the thrombosis is a known inherent risk of use of this device.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 UT 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50351082
• Report Number: 2124215-2026-44907
• Device Sequence Number: 10190183
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)281202(10)38267294
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: VXAK0103
• Device Catalogue Number: VXAK0103
• Device Lot Number: 0038267294
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 12/03/2025
• 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: Other
• Patient Age: 86 YR
• Patient Sex: Male