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

Model Number	VXAK0005
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a left atrial appendage closure (laac) procedure for atrial fibrillation treatment, a versacross connect laac kit was selected for use.The user inserted the rf wire through a needle/sheath.After few advances, there was some resistance noted on the wire.When the wire was pulled out, the tip damage was noted.A coating issue noted thus, the wire was replaced and the procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
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.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.
Additional Manufacturer Narrative
The device has been returned for analysis.Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected and it was observed the ptfe slicing from the distal tip of the rf wire.The cut extends to around 10 cm.The sliced section is still attached to the device on the further end of it.No other damaged observed.Therefore, the reported allegation of coating issue was confirmed.Correction to the initial mdr in block initial reporter phone (e1), in section e - initial reporter.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 was reported that during a left atrial appendage closure (laac) procedure for atrial fibrillation treatment, a versacross connect laac kit was selected for use.The user inserted the rf wire through a needle/sheath.After few advances, there was some resistance noted on the wire.When the wire was pulled out, the tip damage was noted.A coating issue was noted.Thus, the wire was replaced and the procedure was completed successfully.No patient complications occurred.The device has been returned.

• Brand Name: VERSACROSS CONNECT LAAC 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; 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: 21740593
• Report Number: 2124215-2025-19963
• Device Sequence Number: 4007349
• Product Code: DXF
• UDI-Device Identifier: 00685447010517
• UDI-Public: (01)00685447010517
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 07/08/2025

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: VXAK0005
• Device Catalogue Number: VXAK0005
• Device Lot Number: 0034866283
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown