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

Model Number	VXAK0103
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Arrhythmia (1721); Asystole (4442)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a left atrial appendage closure (laac) procedure, a watchman trusteer access system, a 27 mm watchman flx pro laa closure device and delivery system, and a versacross connect laac access solution were selected for use.A transseptal puncture was attempted using the versacross connect system with the trusteer sheath; however, multiple attempts to position the system on the fossa ovalis were unsuccessful, and transesophageal echocardiography (tee) did not adequately demonstrate septal tenting in either the bicaval or short-axis views.During a subsequent repositioning attempt, the patient developed asystole, and transvenous pacing wires were placed via femoral access to manage the arrhythmia.The physician indicated that inadvertent contact with the atrioventricular (av) node during positioning attempts may have contributed to the event.No malfunction was observed with the versacross device during the procedure, and while the patient had a medical history of permanent atrial fibrillation, it could not be determined whether the arrhythmia was related to this pre-existing condition.No information was available regarding medication administration.The patient recovered appropriately without further complications, the procedure was completed as planned, and the patient was discharged home the following day in stable condition.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.It was informed that lot number is not available per account, therefore bsc is unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.

• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 50546471
• Report Number: 2124215-2026-46381
• Device Sequence Number: 13408890
• Product Code: DRE
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: VXAK0103
• Device Catalogue Number: VXAK0103
• 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: 08/03/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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: WATCHMAN FLX Pro LAA Closure Device and Delivery S; WATCHMAN TruSteer Access System (BSC)
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female