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 Air Embolism (1697); Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Unspecified Respiratory Problem (4464)

Event Date 09/19/2023

Event Type  Death  

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 st segment elevations, air embolism, and atrioventricular (av) block occurred.It was reported during a watchman left atrial appendage closure (laac) procedure to treat atrial fibrillation (a fib), a versacross connect solution kit (unknown lot) was selected for use.The transseptal puncture was performed successfully.The watchman sheath was inserted and a non-boston scientific pigtail catheter was introduced into the left atrium.The patient subsequently experienced st segment elevations and av block.It was believed that air may have entered into the system per implanter physician.St elevation/av block was treated medicinally by the staff performed chest compressions were performed, and the patient stabilized.The procedure continued to implant closure device.Following the implant, the patient did not waken.Subsequent tests were performed, and the patient status is unknown and remained in hospitalized.The device return is not expected to be returned.It was versacross connect was used to perform the transseptal puncture.During transseptal puncture, the patient chest would heave upward with an audible, laborious sound of air intake.This was followed by a seemingly interminable pause before the patient would then exhale with a loud-pronounced blast of air and the patient chest losing all the altitude it gained on impact.The entire cycle seemed very loud, labored and tenuous.It is was suspected an air was introduced shortly after the transseptal puncture when the dilator was removed and the pigtail catheter was to be inserted.The hemostasis valve was open and a gurgling sound was audible.This sound occurred during the violent respiratory cycle when the patient chest heaved with a labored inhale of air.The physician may have seen air following the transseptal puncture, while inserting the pigtail catheter.The watchman fxd curve access sheath and pigtail catheter were in the patient when the patient became symptomatic.Complete av block was observed.As per the watchman coordinator, a further scans were done.The patient is deceased.

• 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, qc 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: 17946993
• MDR Text Key: 325793864
• Report Number: 2124215-2023-56638
• 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: 10/16/2023

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: 09/19/2023
• Initial Date FDA Received: 10/16/2023
• 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): Hospitalization; Life Threatening; Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male