MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VersaCross Steerable Access Solution; Introducer, Catheter

Model Number	VSTK0115
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pulsed field ablation (pfa) procedure for the treatment of atypical atrial flutter, a versacross steerable access solution was selected for use.The dilator was inserted into the sheath without resistance, followed by advancement of the farapoint catheter and orion mapping catheter across the valve.No resistance was encountered during insertion of the orion mapping catheter.During the procedure, the physician observed significant leakage from the sheath valve, described as a fast drip of saline during flushing.The syringe was securely attached to the handle luer, and no damage to the device or luer was noted.There was no air leakage or air observed in the patient, and no error messages were displayed.No rf generator was used.The procedure was successfully completed without troubleshooting.The patient remained stable, and no patient complications were reported as a result of the event.

• Brand Name: VersaCross Steerable Access Solution
• Common Device Name: Introducer, Catheter
• 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: 50819349
• Report Number: 2124215-2026-49960
• Device Sequence Number: 10157789
• Product Code: DYB
• UDI-Device Identifier: 00685447019657
• UDI-Public: (01)00685447019657(17)290529(10)85145689
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K190688
• 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
• Report Date (Section B): 09/18/2026

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: VSTK0115
• Device Catalogue Number: VSTK0115
• Device Lot Number: 0085145689
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 05/30/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FARAPOINT ablation catheter (BSC); Orion mapping catheter (BSC)
• Patient Sex: Male