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

Model Number	VXAK0107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pericardial effusion, cardiac tamponade and hypotension.During a left atrial appendage closure (laac) procedure, a versacross rf wire was selected for transseptal access.Prior to the procedure, a small pericardial effusion was identified on imaging.The watchman fxd curve access system (was) with versacross rf wire was positioned posteriorly for the initial transeptal puncture (tsp).The physician reported difficulty advancing the sheath across the septum.A second transseptal puncture was subsequently performed.The rf wire was advanced into the left atrial appendage (laa) and then exchanged for a pigtail catheter.A 24 mm watchman flx pro laa closure and delivery system (wds) was initially selected; however, the device appeared too distally pinched and was removed.The device was exchanged for a 20 mm watchman flx pro wds.The 20 mm watchman flx pro device was successfully deployed and implanted in the laa.At the conclusion of the procedure, the pre-existing pericardial effusion was noted to have increased in size and the patient blood pressure decreased.A pericardiocentesis was performed, and approximately 550 cc of bright red blood was drained from the pericardial space.The patient received one unit of blood transfusion.A pericardial drain was left in place, and the patient was transferred to the intensive care unit (icu) for monitoring and observation.Subsequently, the pericardial drain was removed.The physician suspects the versacross rf wire contributed to the pericardial effusion.The patient was reported to be stable and was discharged from the hospital.

• 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: 50854472
• Report Number: 2124215-2026-50411
• Device Sequence Number: 9953491
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• 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
• Report Date (Section B): 09/22/2026

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: VXAK0107
• Device Catalogue Number: VXAK0107
• Device Lot Number: 0085051942
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 02/10/2026
• 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: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 136 LB