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

Model Number	VXAK0003
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Perforation (2001); Perforation of Vessels (2135)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A perforation has occurred.During a watchman procedure, a versacross connect for laac kit was selected for use.It was noted that when advancing the versacross wire in the right atrium, it went to the patient's left side and entered the left renal vein causing a vascular injury.The versacross rf wire was pulled back and readvanced, and the procedure was completed using the same device.Thus, the vascular injury was repaired.The patient has been discharged.The device is not expected to be returned for analysis (disposed).The wire was kinked at some point when advancing into the body.
Event or Problem Description
A perforation has occurred.During a watchman procedure, a versacross connect for laac kit was selected for use.It was noted that when advancing the versacross wire in the right atrium, it went to the patient's left side and entered the left renal vein causing a vascular injury.The versacross rf wire was pulled back and readvanced, and the procedure was completed using the same device.Thus, the vascular injury was repaired.The patient has been discharged.The device is not expected to be returned for analysis (disposed).The wire was kinked at some point when advancing into the body.
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.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20689220
• Report Number: 2124215-2024-71784
• Device Sequence Number: 20693190
• Product Code: DXF
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0003
• Device Catalogue Number: VXAK0003
• 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: 11/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown