MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS RF WIRE; CATHETER, SEPTOSTOMY

Model Number	VXW-35-230-P
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bmc rf wire was selected for pulse field ablation.During the procedure, radio frequency was applied once, and then, when performing again the transeptal puncture, since the physician was not sure about the position, the radio frequency did not work.Thus, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to be return for analysis.No other issues were reported.
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.
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 found to be out of shape at its tip.Next, the device passed the dimensional test and concluded that the rf wire is within the standard measurements for wire body and proximal end outer diameters.Also passed the tests for electrode height inspection and electrode / heat shrink gap inspection.Finally, the device passed the arc test inspection; the wire was working properly, and the rf was being delivered to the distal end of the wire.Based on the information provided in the complaint summary as well as based on the results of the testing/inspections performed, the reported allegation of failure to cross cannot be confirmed.
Event or Problem Description
It was reported that bmc rf wire was selected for pulse field ablation.During the procedure, radio frequency was applied once, and then, when performing again the transeptal puncture, since the physician was not sure about the position, the radio frequency did not work.Thus, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to be return for analysis.No other issues were reported.The device has returned for analysis.
Event or Problem Description
It was reported that bmc rf wire was selected for pulse field ablation.During the procedure, radio frequency was applied once, and then, when performing again the transeptal puncture, since the physician was not sure about the position, the radio frequency did not work.Thus, the device was replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to be return for analysis.No other issues were reported.The device has returned for analysis.
Additional Manufacturer Narrative
Correction to the follow-up 1 mdr in block d4 unique identifier (udi) #.A complete udi for the device was able to be found.

• Brand Name: VERSACROSS RF WIRE
• 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; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21256482
• Report Number: 2124215-2025-04159
• Device Sequence Number: 20893862
• Product Code: DXF
• UDI-Device Identifier: 00685447003311
• UDI-Public: (01)00685447003311(17)261112(10)35040053
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 05/05/2025

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: VXW-35-230-P
• Device Catalogue Number: VXW-35-230-P
• Device Lot Number: 0035040053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/22/2025; 04/14/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 04/11/2025; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown