MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXAK0109
Medical Device Problem Codes	Off-Label Use (1494); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during the left atrial appendage closure (laac) procedure to treat atrial fibrillation versacross connect laac access solution kit was selected for use.It has been mentioned that physician got access at start of case and tried advancing rf 0.035 j wire through access needle and kept having trouble, when removed the tip of wire was shredded and frayed.The outside coating or core of wire was destroyed.The physician was unaware of any tortuosity or blockage in right femoral vein.Patient didn't have any issues at groin site.Wire and piece were removed successfully.The procedure was finished using a new 0.035 j tip 180cm versa cross connect rf wire.No patient complications have been reported.The product is not expected to be returned as it was disposed.
Event or Problem Description
It was reported that during the left atrial appendage closure (laac) procedure to treat atrial fibrillation versacross connect laac access solution kit was selected for use.It has been mentioned that physician got access at start of case and tried advancing rf 0.035 j wire through access needle and kept having trouble, when removed the tip of wire was shredded and frayed.The outside coating or core of wire was destroyed.The physician was unaware of any tortuosity or blockage in right femoral vein.Patient didn't have any issues at groin site.Wire and piece were removed successfully.The procedure was finished using a new 0.035 j tip 180cm versa cross connect rf wire.No patient complications have been reported.The product is not expected to be returned as it was disposed.
Additional Manufacturer Narrative
Device technical analysis.Device technical analysis it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.Media provided made it possible to confirm the event.

• 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 ; 6514400979
• MDR Report Key: 23959045
• Report Number: 2124215-2026-00288
• Device Sequence Number: 9448285
• Product Code: DXF
• UDI-Device Identifier: 00685447019503
• UDI-Public: (01)00685447019503(17)271202(10)37165254
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: VXAK0109
• Device Catalogue Number: VXAK0109
• Device Lot Number: 0037165254
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown