MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0103
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
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.
Event or Problem Description
It was reported that during left atrial appendage closure procedure, a versacross connect access solution was selected for use.It was mentioned that when device was being prepared it was noted that the inner dilator tip was damaged upon inserting it into the wm sheath.Hence, the device was replaced.Procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that during left atrial appendage closure procedure, a versacross connect access solution was selected for use.It was mentioned that when device was being prepared it was noted that the inner dilator tip was damaged upon inserting it into the wm sheath.Hence, the device was replaced.Procedure was completed successfully.No patient complications occurred.The device is expected to be returned for analysis.It was further reported that the device tip appeared damaged prior to insertion into the sheath.The damage was noted as a crimped appearance at the tip.The method of removing the device from the packaging is not believed to have caused the damage, as the challenging part to remove is the luer lock end, not the tip.The device remained fully intact, and the small piece at the tip was not detached or fragmented.The damage was characterized by a crimped tip, with no sharp or protruding material observed.
Additional Manufacturer Narrative
Due to additional information provided, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b: adverse event or product problem.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.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 22438231
• Report Number: 2124215-2025-45294
• Device Sequence Number: 3152600
• Product Code: DRE
• UDI-Device Identifier: 00685447019473
• UDI-Public: (01)00685447019473(17)280116(10)35910113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 07/30/2025

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: VXAK0103
• Device Catalogue Number: VXAK0103
• Device Lot Number: 0035910113
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/30/2025
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Race: White