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

Model Number	VXAK0007
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that versacross connect laac access solution was selected for left atrial appendage closure.During the procedure, the physician attempted to cross the septum with rf wire four different times, but the rf wire was not able to cross and no error code was noted on the generator.Position of the rf wire was also verified; the septum was thin and had a nice contact.Thus, the rf wire was replaced and the procedure was completed successfully.No patient complication were reported.The device is expected to be return for analysis.The rf was applied all four times and the rf wire was 1-3 mm tent prior to the crossing.Additionally, it was also mentioned that pigtail wire looked normal in shape, but the tip of the wire was black.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the device passed the visual inspection, since no damage was noted to the distal or proximal ends.Tip was charred.Also, the device passed dimensional test for active tip length.Next, the wire passed functional test, for clearance between electrode and heatshrink within specifications.Finally, the device passed dimensional test, as radio frequency was successfully applied to cross tissue (bench test).The reported allegation of failure to cross is not confirmed as the returned device met specifications and successfully crossed sample tissue.The allegation of charring is confirmed based on the returned device.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.Correction to the initial mdr in block(s) init rptr also sent rep to fda (e4), in section e - initial reporter.
Event or Problem Description
It was reported that versacross connect laac access solution was selected for left atrial appendage closure.During the procedure, the physician attempted to cross the septum with rf wire four different times, but the rf wire was not able to cross and no error code was noted on the generator.Position of the rf wire was also verified; the septum was thin and had a nice contact.Thus, the rf wire was replaced and the procedure was completed successfully.No patient complication were reported.The device is expected to be return for analysis.The rf was applied all four times and the rf wire was 1-3 mm tent prior to the crossing.Additionally, it was also mentioned that pigtail wire looked normal in shape, but the tip of the wire was black.

• 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: 21996801
• Report Number: 2124215-2025-29942
• Device Sequence Number: 8815259
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 10/15/2025

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: VXAK0007
• Device Catalogue Number: VXAK0007
• Device Lot Number: 0035595058
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female