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	01/28/2026
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 versacross access solution kit was selected for use.It has been mentioned that the physician was attempting to introduce the dilator and sheath combination into the patient's body but was met with force.When the device was removed, it was noted that the distal end of the sheath had folded/curved back over the dilator.The procedure was completed successfully by using a new versacross system.No patient complications have been reported.The product is not expected to be returning as it was disposed.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific is unable to confirm cause of the reported clinical observation of dilator tip damage.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.Labeling review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion based on the available information, boston scientific's 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 versacross access solution kit was selected for use.It has been mentioned that the physician was attempting to introduce the dilator and sheath combination into the patient's body but was met with force.When the device was removed, it was noted that the distal end of the sheath had folded/curved back over the dilator.The procedure was completed successfully by using a new versacross system.No patient complications have been reported.The product is not expected to be returning as it was disposed.

• 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: 24390898
• Report Number: 2124215-2026-09343
• Device Sequence Number: 16078242
• Product Code: OFK
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280618(10)37725259
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 0037725259
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown