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

Model Number	VXSK0032
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 an atrial fibrillation (a fib) ablation procedure.During the procedure, it was confirmed through ice that the rf wire was exposed and tenting appropriately.However, the rf wire would not cross when rf was applied.The rf settings were adjusted to 2 seconds, yet no change observed.In addition, rewiring and repositioning the rf wire did not result in a change either.Next, the rf wire was replaced, and the procedure was completed successfully.No patient complications reported.Product is available for return.
Additional Manufacturer Narrative
The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.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.
Event or Problem Description
It has been reported that a versacross access solution kit was selected for use for an atrial fibrillation (a fib) ablation procedure.During the procedure, it was confirmed through ice that the rf wire was exposed and tenting appropriately.However, the rf wire would not cross when rf was applied.The rf settings were adjusted to 2 seconds, yet no change observed.In addition, rewiring and repositioning the rf wire did not result in a change either.Next, the rf wire was replaced, and the procedure was completed successfully.No patient complications reported.Product is available for return.It has been further mentioned that rf was delivered and the rf tone was heard from the bmc rf generator but the wire would not cross.Tenting was observed before attempted crossing and wire tip was out of the dilator.Crossing was attempted 5 times and rf was applied each time.No other issues were noted.
Additional Manufacturer Narrative
The device has returned for analysis.Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected and found to be kinked along the length of rf wire and charring on tip was visible confirming that rf was applied number of times during the procedure.Next, the device passed all the device specifications requirements of distal/proximal outer diameters, tip length and tip and heat shrink gap.Additionally, continuity check was performed, and rf wire successfully passed the test.There was difficult inserting the returned rf wire through the dilator because of kinks presented on the rf wire.Tissue testing was performed and successfully punctured the tissue.The reported allegations are not confirmed as rf wire successfully delivered the rf energy and crossed the tissue during bench top testing.The issue was not replicated during the bench top testing.
Event or Problem Description
It has been reported that a versacross access solution kit was selected for use for an atrial fibrillation (a fib) ablation procedure.During the procedure, it was confirmed through ice that the rf wire was exposed and tenting appropriately.However, the rf wire would not cross when rf was applied.The rf settings were adjusted to 2 seconds, yet no change observed.In addition, rewiring and repositioning the rf wire did not result in a change either.Next, the rf wire was replaced, and the procedure was completed successfully.No patient complications reported.Product is available for return.It has been further mentioned that rf was delivered and the rf tone was heard from the bmc rf generator but the wire would not cross.Tenting was observed before attempted crossing and wire tip was out of the dilator.Crossing was attempted 5 times and rf was applied each time.No other issues were noted.The device has been returned for analysis.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• 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: 21561535
• Report Number: 2124215-2025-14478
• Device Sequence Number: 4374069
• Product Code: DXF
• UDI-Device Identifier: 00685447011835
• UDI-Public: (01)00685447011835(17)270801(10)35052743
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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,Followup
• Report Date (Section B): 05/20/2025

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: VXSK0032
• Device Catalogue Number: VXSK0032
• Device Lot Number: 0035052743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 04/22/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/27/2025; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown