MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Model Number	VXSK0134
Medical Device Problem Codes	Mechanical Problem (1384); Off-Label Use (1494); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a procedure to treat atrial fibrillation faradrive steerable sheath and versacross access solution were selected for use.It has been mentioned that the sheath was faulty resulting in significant bleed back from the valve of the sheath and excessive air bubbles in the sheath shaft after transseptal.Versacross access solution had been inside the sheath prior to, and/or at the time, the air was observed.Pump was used for irrigation.The procedure was completed using another device (same model).No air was seen in the patient.No patient complications occurred.The product is not expected to return as disposed.
Event or Problem Description
It was reported that during a procedure to treat atrial fibrillation faradrive steerable sheath and versacross access solution were selected for use.It has been mentioned that the sheath was faulty resulting in significant bleed back from the valve of the sheath and excessive air bubbles in the sheath shaft after transseptal.Versacross access solution had been inside the sheath prior to, and/or at the time, the air was observed.Pump was used for irrigation.The procedure was completed using another device (same model).No air was seen in the patient.No patient complications occurred.The product is not expected to return as disposed.
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) device codes (f10 and h6), in sections f - user facility / importer report information and h - device manufacturers only.It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS 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 ; 6514400979
• MDR Report Key: 23465368
• Report Number: 2124215-2025-79372
• Device Sequence Number: 9950022
• Product Code: DYB
• UDI-Device Identifier: 00685447019893
• UDI-Public: (01)00685447019893(17)280630(10)37289432
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: VXSK0134
• Device Catalogue Number: VXSK0134
• Device Lot Number: 0037289432
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown