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

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

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/16/2023

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 a versacross connect was selected for use during a left atrial appendage occlusion.There was a perforation, a pericardial effusion, and the procedure was cancelled.During transseptal puncture, the physician did not have clear view of tenting on the septum.The physician crossed very posteriorly and through the back wall of the atrium.A perforation on the back wall of the atrium with a small/stable pericardial effusion around the left atrium were noted.The procedure was then cancelled, and patient was taken to the operation room.There was a blood transfusion, a pericardial tap and cardiac surgery for a surgical repair done.The patient was admitted to hospital beyond standard of care, but the patient is doing well, and it was discharged.The device is not expected to be returned for analysis (discarded).No pericardial effusion was noted prior to the procedure.Patient had been given full dose of heparin in therapeutic range.The eliquis was last taken (b)(6) 2023.Aspirin taken 16nov2023.A transesophageal echocardiogram (tee) was used in the procedure.It was about 400ml of blood loss, and blood was given to the patient.No multiple attempts required to track up / drop down into position on septum before tsp was performed.The physician crossed the septum very quickly on first attempt.Imaging doc stated he never visualized a great tent on tee.In the physicians opinion, the very floppy septum was the contributing factor in this scenario.

• 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 ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18307960
• MDR Text Key: 330221649
• Report Number: 2124215-2023-68124
• Device Sequence Number: 1
• Product Code: DRE
• 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: 12/11/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White