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

Model Number	VXSK0101
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
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 a versacross access solutions kit was selected to be used in a procedure to treat atrial fibrillation.Just prior to insertion of the rf wire into the patient, after the wire had been inserted into a short sheath for sheath exchange, the coating was observed to be peeling off the distal tip.No other damage was noted to any accessory devices that could have contributed to the coating issue.The kit was replaced with a similar kit, and the procedure was completed.No patient complications were reported.The kit was disposed and is not expected to return.
Event or Problem Description
It was reported that a versacross access solutions kit was selected to be used in a procedure to treat atrial fibrillation.Just prior to insertion of the rf wire into the patient, after the wire had been inserted into a short sheath for sheath exchange, the coating was observed to be peeling off the distal tip.No other damage was noted to any accessory devices that could have contributed to the coating issue.The kit was replaced with a similar kit, and the procedure was completed.No patient complications were reported.The kit was disposed and is not expected to return.
Additional Manufacturer Narrative
Additional information was provided in section a1 patient identifier, a2 date of birth, a3a, and a3b.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: 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: 24720065
• Report Number: 2124215-2026-17054
• Device Sequence Number: 6110190
• Product Code: DYB
• UDI-Device Identifier: 00685447019749
• UDI-Public: (01)00685447019749(11)250605(17)280604(10)37644463
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2026

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: VXSK0101
• Device Catalogue Number: VXSK0101
• Device Lot Number: 0037644463
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/27/2026; 04/24/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/16/2026; 05/18/2026
• Date Device Manufactured: 06/05/2025
• 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
• Patient Age: 81 YR
• Patient Sex: Female