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

Model Number	VXAK0107
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that flx pro procedure, a versacross connect laac was selected for use.Rf wire was inserted thru the non-boston scientific access needle and was attempted to advance to the superior vena cava (svc).The wire had issues advancing to the svc.After several attempts physician was able to rf across the septum.The watchman dilator was removed and the non-boston scientific pigtail catheter was inserted.After the removal of the rf wire the physician noticed the wires coating was coming off.The procedure was completed and no patient complications reported.
Additional Manufacturer Narrative
Device technical analysis: it was informed that device was returning for analysis, however it was not received; therefore, at this time, a technical analysis of the complaint device could not be completed.A media was provided and upon review, the reported allegation of coating issue was confirmed, as the rf wire insulation was damage at distal tip.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk assessment: a review of the versacross connect laac access solution risk documentation was completed and confirmed that the event of insulation - damaged leading to prolonged procedure was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the available information, boston scientific has assigned a investigation conclusion code of 'failure to follow instructions'.The device has not been returned to bsc for analysis, and the information within the event description including attached image suggests that the use of an introducer needle, which is considered misuse, led to the event.
Event or Problem Description
It was reported that flx pro procedure, a versacross connect laac was selected for use.Rf wire was inserted thru the non-boston scientific access needle and was attempted to advance to the superior vena cava (svc).The wire had issues advancing to the svc.After several attempts physician was able to rf across the septum.The watchman dilator was removed and the non-boston scientific pigtail catheter was inserted.After the removal of the rf wire the physician noticed the wires coating was coming off.The procedure was completed and no patient complications reported.

• 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: 25082296
• Report Number: 2124215-2026-24211
• Device Sequence Number: 10537126
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• UDI-Public: (01)00685447019497(17)290102(10)38323241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 0038323241
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 01/03/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male