MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The versacross dilator was returned with no reported device allegations or patient complications.The user mentioned that the veins going up the groin to the right atrium were very tortuous.The rf wire and versacross dilator were advanced into the svc, along with the trusteer sheath.They mentioned that they had to drop down a few times before the physician decided to pull out the dilator in order to manipulate the curve.During this action, they believe that the rf wire may have also unintentionally slipped back into the sheath and got caught in a sidehole of the trusteer sheath tip.Then, when the dilator was re-advanced, the wire presumably must have pushed through the sheath tip and caused it to tear.The case was continue and completed successfully as the issue was only noted when the devices were removed.They also mentioned that the dilator went across the fossa with no issues, but the sheath took a lot more force to get across the septum.Upon product return, analysis confirmed dilator tip has a slice through it.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the versacross dilator was visually inspected and noted to be kinked at hub-shaft and its tip damage/kinked.Also, the dilator locking mechanism was bent and tip is kinked dilator tip had a slice through it.It is considered most likely that the tip damage and kink were the result of following the wire trajectory through the sheath tip sidehole.With respect to the kink at the hub, there is insufficient information to determine the root cause.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 22125713
• Report Number: 2124215-2025-35805
• Device Sequence Number: 12617797
• Product Code: DRE
• UDI-Device Identifier: 00685447018346
• UDI-Public: (01)00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 06/02/2025

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: VXAK0003
• Device Catalogue Number: VXAK0003
• Device Lot Number: 0035007987
• 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: 05/10/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female