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

Model Number	VSTK0115
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
If was reported that during a pulsed field ablation (pfa) procedure with varipulse to treat an atrial fibrillation, the coating of the versacross wire was coming off and exposed at proximal end of the wire.A new device was used to complete the procedure.No patient complications reported.
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.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of the coating issue.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: it was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.However, the reported allegation is confirmed based on a photo provided.The media showed insulation damage on the rf wire.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).Risk review: a risk review performed for the versacross steerable access solution device confirmed that the event of the coating issue is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the versacross steerable access solution device is acceptable.Investigation conclusion: based on the available information, boston scientifics investigation findings were unable to establish a clear conclusion about the cause of the reported event.The device met all requirements prior to being approved for final distribution/sale and there was no evidence to suggest that the instructions for use (ifu) was not followed.
Event or Problem Description
It was reported that during a pulsed field ablation (pfa) procedure with varipulse to treat an atrial fibrillation, the coating of the versacross wire was coming off and exposed at proximal end of the wire.A new device was used to complete the procedure.No patient complications reported.

• Brand Name: VERSACROSS STEERABLE 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: 24760571
• Report Number: 2124215-2026-18072
• Device Sequence Number: 13373611
• Product Code: OFK
• UDI-Device Identifier: 00685447019657
• UDI-Public: (01)00685447019657(17)281106(10)38411545
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/21/2026

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: 0038411545
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/21/2026
• Date Device Manufactured: 11/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown