MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Dilator, Vessel, For Percutaneous Catheterization

Model Number	VXAK0103
Medical Device Problem Codes	Positioning Failure (1158); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced pericardial effusion.During the transseptal access portion of a left atrial procedure, an versacross connect transseptal dilator was selected for use.Tee was performed and confirmed the absence of a pericardial effusion prior to the start of the procedure.The patient had a preexisting pfo.The physician was attempting transseptal puncture and elected to gain transseptal access via the pfo due to its location being conducive to the watchman procedure.The physician dropped down onto the septum and believed to be aligned with the pfo.A moderate amount of tenting was observed in the area of the pfo.The physician attempted to cross the versacross wire through the pfo without rf and believed the wire crossed into the pericardial space.Prior to crossing, the wire was confirmed to be protruding from the dilator, with approximately 1 mm exposed.The physician did not appear to use excessive force during the attempted crossing.No difficulty was reported with imaging or visualizing the wire.The physician subsequently withdrew the wire, re-tented on the septum, and delivered rf at one second constant during a second attempt.Tsp was completed prior to noticing a pericardial effusion.Multiple track downs were performed because the physician was attempting to cross through the pfo due to its location.The physician then attempted to rewire and drop onto the septum again; however, during that time, a new pericardial effusion was noted to develop.The physician reported a belief that, while attempting to cross using the pfo, the wire may have entered the pericardial space, resulting in the pericardial effusion.Measurements of the effusion were obtained, and protamine was administered to reverse heparin.Tee was used throughout the procedure to monitor the effusion.No intervention was performed.There was no evidence of versacross rf wire malfunction noted by either the physician or clinical staff.No damage was noted on the distal end of the wire when it was removed from the body.The cable was not replaced, as it was not considered defective.Tee was the imaging modality used during the procedure.The procedure was performed by the primary physician.Act was therapeutic during the procedure.Following the procedure, the patient received heparin reversal and was admitted overnight for monitoring.The patient was discharged the following day and is expected to fully recover from the event.The device is not expected to be returned, as it is being retained by the customer.It was further reported that a j-tip rf wire was not used during the procedure; a regular versacross wire was used.

• Brand Name: VersaCross Connect LAAC Access Solution
• Common Device Name: Dilator, Vessel, For Percutaneous Catheterization
• 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: 50135603
• Report Number: 2124215-2026-41821
• Device Sequence Number: 5597646
• Product Code: DRE
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)281202(10)38267294
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 09/16/2026

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: 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: 07/13/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 07/13/2026; 08/31/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/05/2026; 08/11/2026; 09/16/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male