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

Model Number	VXSK0132
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Deliver Energy (1211); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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 versacross access solution selected for use.During procedure, it was tried to cross the septum and unable to process across the septum when activated by the generator.They were not aware of the procedure at that point crossing the septum.Therefore, the procedure was completed successfully by using different device, same model.No patient complication was reported.The device is expected to return for analysis.
Event or Problem Description
It was reported that versacross access solution selected for use.During procedure, it was tried to cross the septum and unable to process across the septum when activated by the generator.They were not aware of the procedure at that point crossing the septum.Therefore, the procedure was completed successfully by using different device, same model.No patient complication was reported.The device is expected to return for analysis.It was further reported that there was no difficult anatomy noted during the case which may have contributed to the issue.There was no difficulty/resistance felt when tracking the wire up/dropping down onto the septum.On fluoro, it was confirmed that the wire was exposed from the sheath 1-3mm.There was 3 times crossing attempted.No one remember whether there was error code or not, but it just made the audible noise it wasn't working.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5) in section b - adverse event or product problem and device codes (f10 and h6), in sections f - user facility / importer report information and h - device manufacturers only.The device has 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.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected and no damage was noted, and due to its condition, it appears to be not used.The device passed also the functional test, as the rf wire successfully punctured tissue through benchtop tissue test.Finally, the rf wire passed the dimensional test since electrode height and gap passed all dimensional criteria.Therefore, the reported allegation of failure to cross are not confirmed as rf wire successfully delivered the rf energy and crossed the tissue during bench top testing.The issue was not replicated during the bench top testing.
Event or Problem Description
It was reported that versacross access solution selected for use.During procedure, it was tried to cross the septum and unable to process across the septum when activated by the generator.They were not aware of the procedure at that point crossing the septum.Therefore, the procedure was completed successfully by using different device, same model.No patient complication was reported.The device is expected to return for analysis.It was further reported that there was no difficult anatomy noted during the case which may have contributed to the issue.There was no difficulty/resistance felt when tracking the wire up/dropping down onto the septum.On fluoro, it was confirmed that the wire was exposed from the sheath 1-3mm.There was 3 times crossing attempted.No one remember whether there was error code or not, but it just made the audible noise it wasn't working.

• Brand Name: VERSACROSS 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: 23480411
• Report Number: 2124215-2025-80009
• Device Sequence Number: 10252367
• Product Code: DXF
• UDI-Device Identifier: 00685447019879
• UDI-Public: (01)00685447019879(17)280401(10)36983861
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 02/12/2026

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: VXSK0132
• Device Catalogue Number: VXSK0132
• Device Lot Number: 0036983861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 01/27/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/25/2025; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown