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

Model Number	VXAK0041
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pseudoaneurysm (2605)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced hemorrhage, pseudoaneurysm.A pulmonary vein isolation (pvi) procedure was performed as planned, with no complications reported.Following completion of the procedure and closure of the access site, the patient was observed to have greater-than-expected bleeding from the incision site.In response, manual pressure was applied and a device was placed to control the bleeding.Subsequently, during post-procedural monitoring, the patient developed a pseudoaneurysm at the access site.The following day, the patient was admitted to the hospital for further evaluation and monitoring.

• 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: 50223119
• Report Number: 2124215-2026-43215
• Device Sequence Number: 5545151
• Product Code: DRE
• UDI-Device Identifier: 00685447019046
• UDI-Public: (01)00685447019046(17)290416(10)39195551
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K233647
• 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
• Report Date (Section B): 08/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0041
• Device Catalogue Number: VXAK0041
• Device Lot Number: 0039195551
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 04/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown