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); Non specific EKG/ECG Changes (1817); Vomiting (2144); Asystole (4442)

Event Date 11/28/2023

Event Type  Injury  

Event Description

It was reported that an air embolism occurred and the procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure to treat falls on oral anticoagulant (oac), a versacross connect kit was selected for use.The procedure was under conscious sedation as the patient could not tolerate general anesthesia.The transseptal puncture was performed and an intracardiac echocardiogram (ice) was used to measure the left atrial appendage (laa).The watchman sheath was advanced into the left atrium and the dilator was removed.Act was 362.There was no bleed back coming from the sheath.During preparation to advance the non-boston scientific pigtail catheter over the versacross rf wire, air bubbles were visualized inside and outside the appendage on the ice images.It was suspected that the air entered when the dilator was removed and patient took a deep causing negative pressure (air lock).St elevations occurred and the patient entered asystole.Chest compressions were initiated and a temporary pacing wire was placed.The patient returned to normal sinus rhythm but started vomiting and was intubated.The coronary arteries were imaged and determined to be clear.Computed tomography (ct) of the brain was performed and small air bubbles were noted.The patient was transferred to the critical care unit to receive hyperbaric oxygen and undergo neurologic assessment.The device is not expected to be returned for analysis.No issues noted during transseptal puncture.Current patient status is that patient is off oxygen but still in critical care, she is awake and doing well but some memory issues.

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.

• 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: 18354805
• MDR Text Key: 330874513
• Report Number: 2124215-2023-71333
• 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: 12/19/2023

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: 11/30/2023
• Initial Date FDA Received: 12/19/2023
• 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; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Race: White