MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Model Number	VXSK0022
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 has been reported that a versacross access solution kit was selected for use for a watchman procedure.During the procedure, the physician mentioned that the mechanical guidewire became stuck in the versacross dilator.The devices were then removed together from the patient and replaced.Procedure was completed successfully.No patient complications were reported.Product is not expected to return for analysis.The mechanical guidewire was exposed to the patient when the issue occurred.No damage noted on the guidewire prior to use, although the guidewire was noted to be kinked when it was removed from the patient.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21297727
• Report Number: 2124215-2025-05504
• Device Sequence Number: 21164233
• Product Code: DYB
• UDI-Device Identifier: 00685447007432
• UDI-Public: 00685447007432
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2025

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: VXSK0022
• Device Catalogue Number: VXSK0022
• Device Lot Number: 0035328384
• 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: 01/15/2025
• Initial Report FDA Received Date: 02/03/2025
• Date Device Manufactured: 08/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male