MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect LAAC Access Solution; Catheter, Septostomy

Model Number	VXAK0107
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radiofrequency (rf) wire could not cross the septum.During a left atrial appendage closure (laac) procedure a versacross connect laac access solution rf wire was used.The versacross connect dilator inside the watchman trusteer sheath was advanced to the superior vena cava (svc) over the rf wire, then the sheath and dilator were dropped onto the septum after transesophageal echocardiography (tee) imaging ensured proper placement to cross the septum the rf wire was advanced outside the dilator 1-2mm.The button on the generator to deliver rf energy was activated, but the wire did not cross the septum.No error message appeared.All connections were checked and another attempt to cross the septum was made, but the wire still did not advance.It was decided to replace the rf wire, and to use a versacross fixed curve sheath with the rf wire.After positioning the sheath and verifying a proper crossing point with tee again, the generator button was activated, and the replacement wire was able to cross the septum.The laac procedure was then continued and completed with no patient complications.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, or if any further relevant information is received, a supplemental medwatch will be filed.

• 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 ; +1(651)440-0979
• MDR Report Key: 25689919
• Report Number: 2124215-2026-35433
• Device Sequence Number: 9720571
• Product Code: DXF
• UDI-Device Identifier: 00685447019497
• UDI-Public: (01)00685447019497(17)290106(10)38335537
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/11/2026

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: 0038335537
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2026
• 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: 06/10/2026
• Supplement Date Received by Manufacturer: 07/02/2026; 08/27/2026
• Initial Report FDA Received Date: 07/02/2026
• Supplement Report FDA Received Date: 07/29/2026; 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female