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

Model Number	VXSK0122
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The physician's full name was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.It was indicated that the device will not be returned for evaluation.Once investigation is complete, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the coating on the wire appeared to be peeling off.The versacross access solution was selected for use for transseptal.The device did not enter the body with the wire.The wire was replaced, and the case was successfully completed.No patient complications occurred.The device is not returning due to disposal.
Additional Manufacturer Narrative
The physician's full name was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.It was indicated that the device will not be returned for evaluation.Once investigation is complete, a supplemental medwatch will be filed.Investigation summary: with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of 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.Risk assessment: a risk review performed for the versacross access solution device confirmed that the event of coating issue is a known event defined in the product's 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 access solution device is acceptable.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).Investigation conclusion: the device has not been returned to bsc for analysis and no media has been provided.The information available is insufficient to determine the root cause, although it suggests it was related to the device itself.Cause linked to device but unable to trace more specifically was therefore selected.Potential causes include physician technique and the inherent step-up from the insulation in the rfw design.
Event or Problem Description
It was reported that the coating on the wire appeared to be peeling off.The versacross access solution was selected for use for transseptal.The device did not enter the body with the wire.The wire was replaced, and the case was successfully completed.No patient complications occurred.The device is not returning due to disposal.

• 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: 24544035
• Report Number: 2124215-2026-12813
• Device Sequence Number: 5662020
• Product Code: OFK
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280220(10)36083565
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 0036083565
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/16/2026
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown