MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number	VMFC061123
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/10/2024
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
A pericardial effusion (pe) occurred.It has been reported that a versacross connect laac access solution kit was selected for use for a left atrial appendage closure (laac) procedure.During the procedure, the versacross connect system was used in combination with the trusteer sheath.Groin access took place successfully, 8000 units of heparin was given to patient, and transseptal access was achieved at a low/posterior point, with no difficulty noted.A few minutes after transseptal, when the versacross system and trusteer were in the left atrium (la), the echocardiologist noticed a small pe.A few manipulations were performed in order to push the versacross wire into the left atrial appendage (laa) without success.It was an aneurysmal septum and tenting of the atrial septum was noted.Shortly after, they identified that the pe was larger (posterior).Once confirmed, the pericardiocentesis was then performed, and the patient remained stable throughout.Later on, the pe was measured to be 2cm.Cell saver was used and the drainage was finished (160 cc in total).Following the intervention, the situation was under control and the laa closure was completed successfully using the original devices.Patient was expected to fully recover, and they were discharged next day.Product is not expected to return for analysis (disposed).No pe was noted prior to the procedure.The patient was not under antiplatelet at the time.There was some difficulty positioning the versacross dilator due to the aneurysmal septum.Additionally, the rf wire was difficult to visualize after transseptal was performed, the successfully crossing was confirmed through visualization of a bubble in the la.No other issues were noted.Act was therapeutic during the procedure.In the physician's opinion, the procedure contributed to the patient complication, since the pericardial effusion happened just few minutes after the transseptal puncture, the physicians confirmed that it was not related to the products.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY 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: 20354096
• Report Number: 2124215-2024-61335
• Device Sequence Number: 3379133
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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 Expiration Date: 08/17/2026
• Device Lot Number: VMFC061123
• 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: 09/10/2024
• Initial Report FDA Received Date: 10/02/2024
• Date Device Manufactured: 11/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown