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

Model Number	VXSK0023
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It has been reported that a versacross access solution kit was selected for use for a pulse field ablation (pvi) procedure with farapulse.After transseptal crossing, when the versacross rf wire was removed, the physician noted that tip of the wire was black.The charring could not be removed.No patient complications reported.The procedure was completed successfully.Product is available for return.No other issues were reported.
Additional Manufacturer Narrative
Due to additional information received, this report is being submitted to updated in the field describe event or problem (b5) in section b adverse event/product prob.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 a pulse field ablation (pvi) procedure with farapulse.After transseptal crossing, when the versacross rf wire was removed, the physician noted that tip of the wire was black.The charring could not be removed.No patient complications reported.The procedure was completed successfully.Product is available for return.No other issues were reported.It was further reported that the radio frequency (rf) was applied twice using the same rf wire on the 1 sec constant setting.
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 using vhx, and charring was noted on distal tip and insulation damage noted on the distal tip.Next, the device passed dimensional testing, since the wire body and proximal end outer diameter, electrode height and electrode/heat shrink gap for the rf wire were within specifications.The reported allegation of charring was then confirmed.However, the code 'no problem detected' was indicated as cause code based on the information provided within the event description along with the returned product analysis.Charring is anticipated through rf delivery in the patient and the user applied less than 5 rf delivery attempts as per the ifu instructions.Therefore, although charring occurred and was confirmed, it is not considered a risk to the patient and is inherent in rf delivery and transseptal puncture workflow.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 a pulse field ablation (pvi) procedure with farapulse.After transseptal crossing, when the versacross rf wire was removed, the physician noted that tip of the wire was black.The charring could not be removed.No patient complications reported.The procedure was completed successfully.Product is available for return.No other issues were reported.It was further reported that the radio frequency (rf) was applied twice using the same rf wire on the 1 sec constant setting.The product has been received 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: 20977297
• Report Number: 2124215-2024-80619
• Device Sequence Number: 18293246
• Product Code: DXF
• UDI-Device Identifier: 00685447007449
• UDI-Public: (01)00685447007449
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/21/2025

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: VXSK0023
• Device Catalogue Number: VXSK0023
• Device Lot Number: 0033937990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 03/31/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/28/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown