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

Model Number	VXAK0101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a versacross connect was used during a procedure.A pre-procedure effusion assessment showed no evidence of effusion.The versacross connect and a trusteer sheath were used to successfully cross the septum, and the pigtail wire was advanced into the left atrial appendage (laa).The septum was subsequently flossed, and a non-boston scientific catheter was advanced into the left atrium (la).The sheath was then re-advanced into the la with the dilator and wire positioned in the laa.After the dilator was removed, the pigtail catheter was advanced over the versacross pigtail wire into the la.During advancement, the wire briefly assumed an infinity-sign shape but quickly returned to its normal pigtail configuration.The pigtail catheter was further advanced over the wire, and the wire was removed from the body.The pigtail catheter was used to navigate into the laa; however, visualization of the catheter position on ice was not possible.A contrast injection was performed, and pericardial staining was observed.Although the patient remained hemodynamically stable, a pericardial effusion was identified.The sheath and catheter were withdrawn from the la, and protamine was administered to reverse heparin.A second physician placed a pericardial drain, and approximately 200 cc of red blood was removed.The drain was left in place, and the patient was transferred to the intensive care unit (icu).No resistance was reported while maneuvering the guidewire.Patient current status is unknown.

• 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: 50543686
• Report Number: 2124215-2026-46249
• Device Sequence Number: 10318400
• Product Code: DXF
• UDI-Device Identifier: 00685447019466
• UDI-Public: (01)00685447019466(17)290505(10)39436747
• 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
• Report Date (Section B): 09/21/2026

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: VXAK0101
• Device Catalogue Number: VXAK0101
• Device Lot Number: 0039436747
• 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: 08/04/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 05/06/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female