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); Hypoxia (1918); Diminished Pulse Pressure (2606); Heart Block (4444)

Event Date 04/08/2024

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 air embolism and death occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac), a versacross connect access solution kit was selected for use.The patient was placed under conscious sedation by a staff registered nurse (rn).Bilateral venous femoral access was obtained.Intracardiac echocardiography (ice) imaging catheter was inserted in one access site and a watchman sheath (was) was inserted via the other access site.Ice was used to visualize the septum for transseptal (tsp) access.Versacross connect was used to successfully complete tsp through the was (mid-inferior) and mid ap approach successfully.The was sheath passed through the septum into the left atrium (la) without difficulty, and the versacross rf wire was noted to be in the left upper pulmonary vein.Thus, the patient began to snore loudly where the nurse noted agonal breathing and poor skin color, suggesting poor oxygenation.An oxygen mask was placed on the patient in an attempt to improve oxygenation.Second prior to this, the hemostasis valve on the watchman sheath was opened to remove the versacross dilator, and the physician visualized air bubbles, noted on ice.At this point, the patient's oxygenation had not improved, and a st segment elevation and atrioventricular (av) heart block were noted.The watchman sheath was pulled back to the right atrium and the versacross rf wire was removed from the la.The patient lost pulses and chest compressions were initiated (code was called).The patient was intubated by anesthesia and despite advanced cardiac life support (acls) resuscitation efforts, the patient died.The procedure was cancelled.The device is not available for analysis.The official cause of death was noted to be probable hypoxia due to air embolism.In the physician's opinion, there was a possibility of air entering the was sheath as the versacross dilator was removed as the was sheath hemostasis valve was opened, as simultaneously the patient was snoring with long pauses observed in breathing rhythm, and with agonal breathing, and additionally the versacross devices did not contributed to patient complications.It was further confirmed that no difficulties were encountered during the transseptal puncture, and no air was visualized prior to removing the versacross dilator from the was sheath.There were no versacross devices malfunctions reported.

• 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: 19193951
• MDR Text Key: 341172273
• Report Number: 2124215-2024-25414
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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
• Date Manufacturer Received: 04/08/2024
• 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): Required Intervention; Death; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Race: White