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

Lot Number VMFC230423

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/02/2023

Event Type  Injury  

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 Description

It was reported that during a left atrial appendage occlusion (laao) procedure, a perforation, pericardial effusion and tamponade occurred.The transseptal puncture was performed; however it was observed after that the versacross rf wire was in the aorta.When checked for effusion, it was present.Physician then performed pericardiocentesis and pulled 400 cc units of blood.Additional surgery consultation was requested to pull the versacross rf wire out, however the effusion came back.Procedure was cancelled and physician then performed cardiac surgery to treat effusion.The hole was patched and appendage was clipped.The patient was admitted to hospital beyond standard of care, it was discarded (date unknown) and expected to fully recover.The device is not expected to be returned for analysis.No other issues were noted.Patient had a very dilated aorta and floppy septum.The transseptal puncture was completed prior to perforation that led to pericardial effusion.It is believed that the dilated aorta tissue connecting to the left atrium was "stretched out and very friable" against the wire causing the perforation.Act was not documented.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: 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: timothy degroot degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17624776
• MDR Text Key: 321966900
• Report Number: 2124215-2023-45119
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2023

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
• Device Operator: Health Professional
• Device Lot Number: VMFC230423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention