MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXSK0032
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, a versacross access solution kit was selected for use, the radio frequency (rf) wire could not perform transseptal puncture as it did not cross the septum.The rf delivery was attempted around five times but crossing the septum could not be performed.To troubleshoot, the staff confirmed that the appropriate amount of the rf wire was exposed outside the dilator.No difficult anatomy was noted during the case which may have contributed to the issue.There were no errors displayed on the rf generator, but the wire wasn't able to cross the septum despite appropriate wire exposure.Upon removal of the rf wire the tip of the wire was black, no damage was noted prior to the procedure.Gentle forward pressure was applied during the duration of the radio frequency application.A new versacross access solution kit was opened the radio frequency wire worked fine and the procedure was completed successfully.No patient complications were reported.The device is available for return.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and 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.
Additional Manufacturer Narrative
This supplemental mdr is submitted to report investigation results (mdr aware date 27sep2023).The device was received for analysis.Upon inspection, the device met its design specification for the wire body outer diameter, proximal end outer diameter, electrode height, and electrode/heat shrink gap.A visual and dimensional test took place and concluded that the rf wire is within the standard measurements, and no char was observed on the tip of the wire.Additionally, an arc testing was completed to confirm if rf is delivered to the distal end of the wire.All testing confirmed that the wire is working properly, and that rf is being delivered to the distal end of the wire.
Event or Problem Description
It was reported that during an ablation procedure, a versacross access solution kit was selected for use, the radio frequency (rf) wire could not perform transseptal puncture as it did not cross the septum.The rf delivery was attempted around five times but crossing the septum could not be performed.To troubleshoot, the staff confirmed that the appropriate amount of the rf wire was exposed outside the dilator.No difficult anatomy was noted during the case which may have contributed to the issue.There were no errors displayed on the rf generator, but the wire wasn't able to cross the septum despite appropriate wire exposure.Upon removal of the rf wire the tip of the wire was black, no damage was noted prior to the procedure.Gentle forward pressure was applied during the duration of the radio frequency application.A new versacross access solution kit was opened the radio frequency wire worked fine and the procedure was completed successfully.No patient complications were reported.The device is available for return.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16978223
• Report Number: 2124215-2023-20898
• Device Sequence Number: 6480498
• Product Code: DXF
• UDI-Device Identifier: 00685447011835
• UDI-Public: 00685447011835
• 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
• Report Date (Section B): 10/20/2023

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 Expiration Date: 01/19/2025
• Device Model Number: VXSK0032
• Device Lot Number: VXF170223A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown