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

Model Number	VXSK0121
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during the pulse field ablation procedure to treat atrial fibrillation versacross access solution kit was selected for use.It has been mentioned that the coating came off in the middle of versacross wire.The procedure was completed successfully by using a different device (same model, boston scientific product).No patient complications have been reported.The product is expected to be returned.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during the pulse field ablation procedure to treat atrial fibrillation versacross access solution kit was selected for use.It has been mentioned that the coating came off in the middle of versacross wire.The procedure was completed successfully by using a different device (same model, boston scientific product).No patient complications have been reported.The product is expected to be returned.It was further reported, the damage was observed after the wire and dilator were removed.The wire was pulled back into the sheath/ dilator once the sheath was in the superior vena cava (svc).The wire was then pulled back again when removed.The dilator was already backloaded onto the wire/inside the patient.

• 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: 24650221
• Report Number: 2124215-2026-15506
• Device Sequence Number: 10208050
• Product Code: OFK
• UDI-Device Identifier: 00685447019817
• UDI-Public: (01)00685447019817(17)280629(10)37688566
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2026

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: VXSK0121
• Device Catalogue Number: VXSK0121
• Device Lot Number: 0037688566
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/26/2026; 04/30/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/13/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male