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 Code	Pericardial Effusion (3271)
Date of Event	06/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, if additional information is received, supplemental report will be submitted.
Event or Problem Description
It was reported that a patient experienced a pericardial effusion.This patient has a pant leg type left atrial appendage.Versacross connect was used for tsp and crossed with the first buzz.First a 24mm watchman device was attempted, then a 20 mm watchman device.There was not enough space on either side of the bifurcating pectinate for a watchman device to expand and anchor into tissue.Every deployment either pushed proximal or tugged proximal into an unacceptable position.There were 7 deployment attempts with the 24mm device and 5 attempts with the 20mm device.Then the physician decided to attempt an amulet implant instead.Prior to switching to amulet, the imaging physician did an effusion sweep and confirmed there was no effusion at the end of the watchman attempts.There was a fat pad present that looked the same as prior to case start.The physicians all reviewed pre procedure images and end of watchman case images.They then proceeded to try a 22mm amulet, which did not work so they downsized to a 20mm amulet device.This device was released.Case ended around 4:30 pm, the patient was admitted overnight.A notification was received the following afternoon by the sonographer that was in the case, that the patient was found to have a large pericardial effusion.He said there was no effusion seen at the end of the amulet case time.He reported that approximately 300cc of blood was drained during the pericardiocentesis.

• 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: 25882012
• Report Number: 2124215-2026-38903
• Device Sequence Number: 8103833
• Product Code: DXF
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)281110(10)38167037
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/16/2026

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: 0038167037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 07/21/2026; 08/30/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 08/13/2026; 09/16/2026
• Date Device Manufactured: 11/11/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 180 LB