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

Model Number	VXAK0003
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	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the physician mentioned that after inserting the versacross rf wire through a non-boston scientific introducer needle, the tip of the rf wire was noted to be stripped once it was removed.It was peeled back near the distal end, but still intact.Hence, a new kit was then opened to be used, and the procedure was completed successfully.No patient complications reported.Product is expected to return 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.
Event or Problem Description
It has been reported that a versacross connect laac access solution kit was selected for use for a watchman procedure.During the procedure, the physician mentioned that after inserting the versacross rf wire through a non-boston scientific introducer needle, the tip of the rf wire was noted to be stripped once it was removed.It was peeled back near the distal end, but still intact.Hence, a new kit was then opened to be used, and the procedure was completed successfully.No patient complications reported.The device has returned for analysis.
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 have a ptfe damage noted on the distal tip of the wire (skiving of rf wire confirmed at distal end).The device passed the test for wire body and proximal end outer diameters.Also, the rf wire passed the tests for inspection of electrode height and electrode/heat shrink gap inspection.The reported allegation of coating issue was confirmed for the ptfe skiv on the rf wire.The cause code 'unintended use error cause or contributed to event' was selected, since it is highly likely that the damage to the rf wire was caused by inserting the wire through an introducer needle, as reported.The instructions for use of the rf wire includes the warning 'do not attempt to insert or retract the versacross rf wire through a metal cannula or a percutaneous needle, which may damage the device and may cause patient injury.

• 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; 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: 21313193
• Report Number: 2124215-2025-05911
• Device Sequence Number: 18147588
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/20/2025

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: VXAK0003
• Device Catalogue Number: VXAK0003
• Device Lot Number: 0034826035
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown