MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; CATHETER, SEPTOSTOMY

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Diminished Pulse Pressure (2606); Pericardial Effusion (3271)

Event Date 02/07/2024

Event Type  Death  

Event Description

It was reported a patient death occurred.During a watchman left atrial appendage closure (laac) procedure to treat atrial fibrillation (a fib) bleed and stroke risk, a versacross large access solution kit was selected for use.Prior to the procedure, all pre-checks were performed and no clot or effusion was noted.The transseptal puncture was performed at low-posterior side however the physician struggled to advance the watchman sheath and a non-boston scientific pigtail catheter into the appendage for a contrast shot.Hence, another transseptal puncture was performed at low-anterior which was an atrial septal defect (asd) location.The sheath and pigtail were advanced and a contrast shot was given.Following to the contrast shot and preparation for the implant device, a smoke was noted on the imaging which was then later confirmed that an effusion was forming near the right ventricle.The anesthesiologist noted patient pressure dropped and had no pulse.The procedure was cancelled immediately.A pericardiocentesis was performed however the effusion remained unchanged with still no pulse.A cardiothoracic surgeon then performed pericardial window and got patient stabilized with a pulse.The patient was taken to the operation room and later it was confirmed that the patient died.The device is not expected to be returned for analysis.It was further confirmed that the exact cause of death was unknown.Patient had a difficult orientation of the fossa in relation to where the appendage was.Tenting the septum on the first stick was with no issue, the second transseptal went through an old asd.Transesophageal echocardiogram (tee) was used for imaging.The watchman sheath or non-boston scientific pigtail wire could not be visualized on first transseptal when maneuvering to the appendage, second one was able to visualize sheath into the appendage for a contrast shot.It was mentioned there was a hole that was patched where the tap tray was used near the right ventricle.Aside from that, it was not mentioned what caused the effusion.538 was the act reading.No difficulties-malfunctions noted with versacross device (rf wire or dilator).

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 ACCESS SOLUTION
• Type of Device: CATHETER, SEPTOSTOMY
• 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: 18815761
• MDR Text Key: 336646152
• Report Number: 2124215-2024-12007
• Device Sequence Number: 1
• Product Code: DXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150709
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 02/07/2024
• 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): Death; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Race: White