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 Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	08/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion and cardiac tamponade occurred.A left atrial appendage closure (laac) procedure was being performed.A versacross connect laac access solution kit, watchman fxd curve access system and a 20mm watchman flx pro delivery system were selected for use.The patient was noted to have a small appendage, making the procedure more challenging.After two attempts and recaptures of the 20mm device a larger 24mm wds was deployed.As the physician checked the views on the transesophageal echocardiography (tee) the patient blood pressure dropped.A growing effusion was noted.The physician prepped for pericardiocentesis, and anesthesia worked on stabilizing blood pressure.Cardiac surgery was called in as back up.A pericardial drain was placed and about 450 ml of blood was drained at this point.The 24mm wds and the double curve was were removed.The patient was given protamine to reverse anticoagulation.About 1200ml of blood was drained.The blood was re-transfused back into the patient, and an additional two units of blood were given.The patient continued to decline and was brought to the operating room where the laa was clipped.After clipping the appendage the patient was stable.The device is not expected to be returning as it has been disposed.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• 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 ; CA 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50615752
• Report Number: 2124215-2026-47377
• Device Sequence Number: 13418243
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 0039429612
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 05/07/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Female