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

Model Number	VXAK0107
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	08/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion occurred.Versacross connect access solution was selected for use.Transesophageal echocardiography (tee) imaging noted a trace effusion prior to the procedure.The initial transeptal puncture (tsp) was difficult to perform due to a sharp posterior-inferior bend in the patient's anatomy.The physician attempted to cross the septum several times using the versacross connect wire, crossing was made with the same rf wire.A proximal and distal bend were added to the trusteer sheath and dilator, same dilator was use.After physician deployed the closure device, and completed a sweep, tee imaging showed no change in effusion.Approximately thirty minutes post deployment, the patient's blood pressure dropped.Tee imaging noted the effusion near the apex of the left ventricle.Physician performed a pericardiocentesis to treat the effusion, draining an unknown amount of dull colored fluid.Patient was stabilized and was admitted to intensive care unit.There were no further complications and approximately three days post procedure, the patient was discharged.

• 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: 50568660
• Report Number: 2124215-2026-46831
• Device Sequence Number: 10533274
• Product Code: DRE
• UDI-Device Identifier: 00685447019497
• UDI-Public: (01)00685447019497(17)290517(10)39527846
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 10/02/2026

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: VXAK0107
• Device Catalogue Number: VXAK0107
• Device Lot Number: 0039527846
• 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: 08/07/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/02/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 05/18/2026
• 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: 71 YR
• Patient Sex: Male