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

Model Number	VXAK0003
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a versacross connect laac access solution was selected for use during a watchman procedure.During preparation, upon opening the packaging for the versacross connect it was noted that the distal tip of the dilator was damaged, like a rip.Thus, a new kit was opened to be used.The procedure was completed successfully.No patient complications were reported.Product return is expected.It says that the material was buckled, prior to advance into the sheath.No other issues were reported.
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.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the dilator was visually inspected and confirmed to have a tip and taper damage, aligned with tip damage.Also, a minor scrapping was noted along its distal end.Additionally, the device passed flushing tests.The reported allegation of dilator tip damage was confirmed based on the product investigation.
Event or Problem Description
It was reported that a versacross connect laac access solution was selected for use during a watchman procedure.During preparation, upon opening the packaging for the versacross connect it was noted that the distal tip of the dilator was damaged, like a rip.Thus, a new kit was opened to be used.The procedure was completed successfully.No patient complications were reported.Product return is expected.It says that the material was buckled, prior to advance into the sheath.No other issues were reported.The device has returned for analysis.

• 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: 21103464
• Report Number: 2124215-2024-83107
• Device Sequence Number: 8637387
• Product Code: DRE
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 03/20/2025

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: 0034775459
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown