MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Connect Access Solution for FARADRIVE; dilator, vessel, for percutaneous catheterization

Model Number	VXAK0041
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulsed field ablation procedure, a versacross connect was selected for use.During procedure, the device could not get reach on the transeptal.Opened the versacross fixed sheath and issue was resolved.There were no patient complications.

• Brand Name: VersaCross Connect Access Solution for FARADRIVE
• Common Device Name: dilator, vessel, for percutaneous catheterization
• 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: 25513191
• Report Number: 2124215-2026-31868
• Device Sequence Number: 13260324
• Product Code: DRE
• UDI-Device Identifier: 00685447019046
• UDI-Public: (01)00685447019046(17)281102(10)37875864
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/23/2026

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: 0037875864
• Was Device Available for Evaluation?: No
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown