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

Model Number	VXAK0045
Medical Device Problem Codes	Nonstandard Device (1420); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, access was obtained and an 8fr sheath was placed for guidewire access; however, when attempting to advance the versacross dilator and faradrive sheath over the guidewire, the system became stuck upon entering the groin, and the dilator tip was deformed due to patient anatomy, leading to replacement of the dilator with a new versacross connect kit.The device was replaced, and the procedure was completed without patient complications.The device is not expected to return for laboratory analysis since it was disposed.

• 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: 25167423
• Report Number: 2124215-2026-26042
• Device Sequence Number: 13422744
• Product Code: DRE
• UDI-Device Identifier: 00685447019060
• UDI-Public: (01)00685447019060(17)280909(10)37499957
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K233647
• 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): 08/28/2026

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: VXAK0045
• Device Catalogue Number: VXAK0045
• Device Lot Number: 0037499957
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 09/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown