MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VERSACROSS ACCESS SOLUTION; PERCUTANEOUS ATRIAL CATHETER KIT

Model Number	VXSK0122
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that versacross access solution was selected for use.During the procedure when an attempt was made for femoral vein access from the groin, the dilator had resistance and could not be advanced into the vein.When it was withdrawn, the distal end was found to be rolled back at the end like a sleeve.The dilator was not fully introduced into the vessel.Thus, the device was replaced and the procedure was completed successfully.No patient complication was reported.The device is not expected to be return as disposed.
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 versacross access solution was selected for use.During the procedure when an attempt was made for femoral vein access from the groin, the dilator had resistance and could not be advanced into the vein.When it was withdrawn, the distal end was found to be rolled back at the end like a sleeve.The dilator was not fully introduced into the vessel.Thus, the device was replaced and the procedure was completed successfully.No patient complication was reported.The device is not expected to be return as disposed.
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.However, the reported allegation is confirmed via the media provided.Labelling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described withing this complaint.No updates are required to the ifu as a result of this event.Risk review: upon review of the complaint, the information provided does not indicate a new hazardous situation.Device history record (dhr) review: the lot numbers associated with the sheath for vxsk lot 38038932 are: 37826286 & 37881128 there were no non-conformances associated with either lot.There were rejects associated with both lots.However, neither of these rejects reasons would cause the event that occurred.The device has not been returned to bsc for analysis; however, the allegation was confirmed via media provided.The root cause cannot be determined with certainty based on the information available, and the conclusion code "cause linked to device but unable to trace more specifically" was therefore selected.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: PERCUTANEOUS ATRIAL CATHETER KIT
• 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: 24333558
• Report Number: 2124215-2026-08249
• Device Sequence Number: 9799505
• Product Code: OFK
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)281007(10)38038932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/13/2026

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: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0038038932
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown