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

Model Number	VXSK0121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a left atrial appendage (laa) procedure under general anesthesia, a versacross access solution was used for transseptal access.Baseline imaging with tee identified a pre-existing pericardial effusion measuring 0.7 cm, with fluid noted behind the laa and around the rv.A non-boston scientific mapping catheter was used intra-procedurally.The physician performed a transseptal puncture using an 8.5f fixed versacross sheath and versacross pigtail wire.After the wire was advanced into the laa and the sheath withdrawn, a non-boston scientific sheath was loaded over the wire.At that time, the ice representative noted a growing pericardial effusion, which was subsequently confirmed by tee.The patient became hemodynamically unstable with a drop in blood pressure, prompting emergent pericardiocentesis.Approximately 1,500 ml of bright red blood was evacuated and returned to the patient via cell saver autotransfusion.Due to continued blood re-accumulation, the patient was transferred to surgery, where an laa perforation attributed to the versacross wire was reportedly confirmed and managed with a pericardial window and laa clipping.On the following day, the patient was reported to be doing well, with planned extubation later that evening.The patient was not receiving antithrombotic therapy.The patient recovered very quickly and was discharged the same week of the event.The device was disposed.

• Brand Name: VersaCross 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: 50933346
• Report Number: 2124215-2026-51684
• Device Sequence Number: 10759270
• Product Code: DFX
• UDI-Device Identifier: 00685447019817
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/29/2026

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: VXSK0121
• Device Catalogue Number: VXSK0121
• Device Lot Number: 0039768030
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 04/15/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown