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); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Respiratory Failure (2484); Asystole (4442)

Event Date 09/27/2023

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 an air embolism occurred.During a watchman left atrial appendage closure (laac) procedure, a versacross connect kit and watchman access sheath was selected for use.After the transseptal puncture (tsp) was completed and versacross devices were removed, the patient became hypotensive and atropine was administered.It was observed the hemostasis valve on the watchman sheath was not completely closed and an air embolism occurred in the left atrium.The physician believes, an air entered via sheath which was in left atrium while patient was asleep and heavily breathing before it was closed down tightly.Air was not visualized on intracardiac echocardiography (ice) or fluoroscopy.The patient noted without a pulse (asystole); cardiopulmonary resuscitation (cpr) and rapid pacing were performed and the patient was intubated.After five to seven minutes, the patient regained pulse.The procedure was completed with the successful implantation of the closure device.The patient remained hospitalized and intubated due to acute hypoxic respiratory failure.The device is not expected to be returned for analysis.It was further confirmed, the patient is in palliative care.

• 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: 18005193
• MDR Text Key: 326516767
• Report Number: 2124215-2023-59009
• 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: 10/25/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/25/2023
• 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; Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male