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

Model Number	VXSK0124
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	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that versacross access solution was selected for atrial fibrillation (a fib).During the procedure, it was mentioned they tried to use the rf wire with the vizigo sheath for transseptal puncture, which was not intended to use.As a result, the coating around the wire stripped off.Thus the rf was replaced and the procedure was completed successfully.No patient complication were reported.The device is not expected to be returned for analysis (disposed).
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.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the reported allegation of insulation damage was confirmed based on the media.Correction to the initial mdr in block init rptr also sent rep to fda (e4), in section e - initial reporter.
Event or Problem Description
It was reported that versacross access solution was selected for atrial fibrillation (a fib).During the procedure, it was mentioned they tried to use the rf wire with the vizigo sheath for transseptal puncture, which was not intended to use.As a result, the coating around the wire stripped off.Thus the rf was replaced and the procedure was completed successfully.No patient complication were reported.The device is not expected to be returned for analysis (disposed).23jun2025: ai received- media provided.

• 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: 22481192
• Report Number: 2124215-2025-46451
• Device Sequence Number: 12886280
• Product Code: DXF
• UDI-Device Identifier: 00685447019848
• UDI-Public: (01)00685447019848(17)280210(10)36233599
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/18/2025

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: VXSK0124
• Device Catalogue Number: VXSK0124
• Device Lot Number: 0036233599
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/18/2025
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown