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

Lot Number VXFA020622

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/26/2024

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), a versacross access solution kit was selected for use.The intracardiac echocardiography (ice) was used to clear thrombus from pulmonary artery.Immediately upon going transseptal puncture, the blood pressure tanked, heart rate rose and a large effusion was noted.A pericardial access was achieved, and tapping was continuous, but effusion was not resolving.The physician decided to place the watchman device to try to slow the bleeding as the angiogram showed some dye extrapolation was seen out of the appendage.The effusion started to get slightly better with continuous tapping.The patient coded and compressions were started along with intubation.The surgery was called and cracked the chest but they could not get the patient heart to restart and the patient passes away on the table.In the physician opinion the versacross wire lacerated the left atrial appendage (laa).The device is not expected to be returned for analysis.It was further confirmed there was no thrombus present in pa (pulmonary artery).No issues were noted during tsp, which was achieved in first attempt with no track up and down.The pericardial effusion (pe) was located everywhere which was noted almost immediately after the tsp.Heparin was administered at groin access.Protamine was given after pericardial effusion was noted.Immediately after crossing the versacross wire went into the mouth of the appendage and was moved to the vein.The was sheath was not across when the pe was noticed.During surgery they found that the back of the appendage had a large hole.It was somehow lacerated open by the entrance of the wire into the prior to moving to the vein.

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 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: 18949057
• MDR Text Key: 338232110
• Report Number: 2124215-2024-16252
• Device Sequence Number: 1
• Product Code: DXF
• UDI-Device Identifier: 00685447011729
• UDI-Public: 00685447011729
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: VXFA020622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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: 86 YR
• Patient Sex: Female
• Patient Race: White