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

Model Number	VXSK0011
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, 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 a transcatheter aortic valve replacement (tavr) procedure.It was mentioned that during the procedure, the tip of the rf wire was noted char (black).Keep showing error code metal detected.Thus, the device was replaced, and the procedure was completed successfully.The reason behind the event is unknown.The problem associated with labeled use.The event occurred inside the patient body and no patient complication were reported.The device is not expected to be return for analysis (disposed).It was mentioned that rf was delivered 5 times.Act was over 300s.Heparin was administered before the femoral access.
Additional Manufacturer Narrative
The device did not return for analysis.However, the reported allegation of charring on the distal end of the wire was observed on the media provided, which is expected after multiple rf deliveries.The allegation of an error code appearing on the generator could not be verified based on the provided media.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 transcatheter aortic valve replacement (tavr) procedure.It was mentioned that during the procedure, the tip of the rf wire was noted char (black).Keep showing error code metal detected.Thus, the device was replaced, and the procedure was completed successfully.The reason behind the event is unknown.The problem associated with labeled use.The event occurred inside the patient body and no patient complication were reported.The device is not expected to be return for analysis (disposed).It was mentioned that rf was delivered 5 times.Act was over 300s.Heparin was administered before the femoral access.

• 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: 21920181
• Report Number: 2124215-2025-26850
• Device Sequence Number: 13030047
• Product Code: DXF
• UDI-Device Identifier: 00685447007326
• UDI-Public: (01)00685447007326
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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 Expiration Date: 01/26/2026
• Device Model Number: VXSK0011
• Device Catalogue Number: VXSK0011
• Device Lot Number: VXFA120923
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 03/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male