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

Model Number	VXAK0041
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during post procedure/prior to discharge for a pulse field ablation (pfa) procedure a versacross connect access solution for faradrive rf wire was selected for use.Posterior to transseptal procedure using versacross connect, the wire could not be removed from the dilator.The procedure was completed with original device.No patient complications were reported.

• Brand Name: VersaCross Connect Access Solution for FARADRIVE
• 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: 50399362
• Report Number: 2124215-2026-45287
• Device Sequence Number: 13375647
• Product Code: DXF
• UDI-Device Identifier: 00685447019046
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: VXAK0041
• Device Catalogue Number: VXAK0041
• Device Lot Number: 0039560215
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 05/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown