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

Model Number	VXAK0101
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.A separated report for the versacross dilator is being submitted.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.
Event or Problem Description
It was reported that versacross connect laac access solution was selected for pulmonary vein isolation.During the procedure when versacross connect for faradrive was inserted into the body for sheath exchange from access sheath to faradrive sheath for transseptal puncture (tsp), the versacross wire tip tangled on itself and was not able to freed up with maneuvering by physician.Thus, a new verscross kit was opened to be used.Hence, the tip of the dilator appeared to be folded back a small amount.The procedure was completed successfully with alternative device.No patient complications were reported.The device is not expected to be return for analysis (disposed).

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22495175
• Report Number: 2124215-2025-46786
• Device Sequence Number: 8094103
• Product Code: DXF
• UDI-Device Identifier: 00685447019466
• UDI-Public: (01)00685447019466
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 07/14/2025

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: VXAK0101
• Device Catalogue Number: VXAK0101
• 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: 06/24/2025
• Initial Report FDA Received Date: 07/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown