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

Model Number	VXSK0132
Medical Device Problem Codes	Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.
Event or Problem Description
It was reported that during an atrial fibrillation ablation procedure, a versacross access solution was selected for use.During femoral access, the physician placed the versacross wire through a non-boston scientific cook needle into the femoral vein.The wire would not advance and when retracting the wire back through the needle it was noted that the coating of the wire near the pigtail was damaged from the needle.The wire was replaced with a wire from another kit.The procedure was completed successfully.No patient complications occurred.The device has been received at boston scientific's post market laboratory where it is awaiting analysis.
Event or Problem Description
It was reported that during an atrial fibrillation ablation procedure, a versacross access solution was selected for use.During femoral access, the physician placed the versacross wire through a non-boston scientific cook needle into the femoral vein.The wire would not advance and when retracting the wire back through the needle it was noted that the coating of the wire near the pigtail was damaged from the needle.The wire was replaced with a wire from another kit.The procedure was completed successfully.No patient complications occurred.The device has been received at boston scientific's post market laboratory where it is awaiting analysis.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected and noted to have its ptfe coating skived near the distal tip.An insulation damage was noted on the rf wire.The returned device met its design specification for the distal and proximal outer diameters.It was confirmed that the rf wire was inserted through metal needle, which led to insulation damage.Therefore, the cause code "failure to follow instruction" was selected.The reported allegation has been confirmed.A label review of ifu includes the warning 'do not attempt to insert or retract the versacross rf wire through a metal cannula or a percutaneous needle, which may damage the device and may cause patient injury.' correction to the initial mdr in block(s) init rptr also sent rep to fda (e4), in section e - initial reporter.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22309672
• Report Number: 2124215-2025-41197
• Device Sequence Number: 12747075
• Product Code: DXF
• UDI-Device Identifier: 00685447019879
• UDI-Public: (01)00685447019879
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 08/20/2025

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: VXSK0132
• Device Catalogue Number: VXSK0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown