MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Percutaneous atrial catheter kit

Model Number	VXAK0105
Medical Device Problem Codes	Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a left atrial appendage closure procedure, a versacross was selected for use.The physician obtained groin access and performed a transseptal puncture with the versacross connect as normal.The trusteer was advanced to the left side of the heart and exchanged for a pigtail wire to take a contrast shot.While attempting to advance the sheath, the physician noted difficulty and resistance.Fluoroscopy was performed, revealing a kinked sheath.At that point, a new trusteer was opened, and no effusion was observed.To exchange, the versacross pigtail wire was re-advanced to the left side to maintain the same transseptal puncture.The second trusteer was advanced smoothly to the left side without resistance.However, an effusion was then noted, and the physicians prepared for a pericardiocentesis.A cardiac tamponade also occurred.Approximately 200cc of fluid was drained, protamine was administered and the effusion stabilized.The physician believed the effusion occurred while exchanging.Due to the effusion, the decision was made not to proceed with watchman implantation.It was also reported that resistance was encountered when attempting to advance the trusteer closer to the appendage.The guidewire used was the wire included in the versacross connect box.The patient was held overnight and discharged with no further treatment post complication.

• Brand Name: VersaCross Connect LAAC Access Solution
• Common Device Name: Percutaneous atrial catheter kit
• 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: 50306522
• Report Number: 2124215-2026-44376
• Device Sequence Number: 10134958
• Product Code: DXF
• UDI-Device Identifier: 00685447019480
• UDI-Public: (01)00685447019480(17)290427(10)39368403
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 09/30/2026

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: VXAK0105
• Device Catalogue Number: VXAK0105
• Device Lot Number: 0039368403
• 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: 07/27/2026
• Supplement Date Received by Manufacturer: 08/28/2026; 09/28/2026
• Initial Report FDA Received Date: 08/18/2026
• Supplement Report FDA Received Date: 09/17/2026; 09/30/2026
• Date Device Manufactured: 04/28/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: M635TU90050/WATCHMAN TRUSTEER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female