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

Model Number	VXAK0107
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a pulse field ablation (pfa) procedure a transseptal dilator from the versacross connect laac access solution was selected for use, it was noted that the packaging was compromised, sterile seal had a gap.The versacross system was replaced, and the procedure was completed successfully.No patient complications were reported, event occurred before patient came into the laboratory.The device is not expected to be returned.

• 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: 25791588
• Report Number: 2124215-2026-37295
• Device Sequence Number: 18816339
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• UDI-Public: (01)00685447019497(17)290427(10)39350460
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0107
• Device Catalogue Number: VXAK0107
• Device Lot Number: 0039350460
• 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: 06/17/2026
• Supplement Date Received by Manufacturer: 07/22/2026; 08/28/2026
• Initial Report FDA Received Date: 07/12/2026
• Supplement Report FDA Received Date: 08/17/2026; 09/16/2026
• Date Device Manufactured: 04/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown