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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	12/19/2024
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.A separate problem report will be filed for the versacross rf wire.
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross connect for laac kit was selected for use.The physician lost left atrium access from the first transseptal hence intracardiac echocardiography (ice) was pulled back to right atrium (ra).The second transseptal was completed.The physician advanced the sheath and dilator into left atrium.Ice was then moved into right ventricular out pulmonic valve into the pulmonary artery (pa).The appendage was visualized to confirm sheath and dilator access in left atrium (la).Both sheath and dilator were visualized near appendage.Physician pulled ice back out towards ra from pa when effusion was visualized.A pericardiocentesis was performed.The patient remained hemodynamically stable, expected to make full recovery, and was hospitalized overnight for observation.The patient has been discharged later.The device is not expected to be returned for analysis (disposed).The patient was not under warfarin nor antiplatelet drugs at the time.The la lost access happened during manipulation with was, trying to engage with left atrium appendage (laa).Also, the ice catheter was not acting normal (not returning to neutral when unlocked).The physician suspected perforation was in the laa, and the versacross rf wire and/or dilator may have perforated, however no device malfunctions noted during procedure.

• 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): 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: 21118443
• Report Number: 2124215-2024-83506
• Device Sequence Number: 18008136
• Product Code: DRE
• UDI-Device Identifier: 00685447018346
• UDI-Public: 00685447018346
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 01/09/2025

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: 12/19/2024
• Initial Report FDA Received Date: 01/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Race: White