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

Lot Number	VXFA020622
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	02/26/2024
Type of Reportable Event	Death
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2124215-2024-16252
• Device Sequence Number: 8161533
• Product Code: DXF
• UDI-Device Identifier: 00685447011729
• UDI-Public: 00685447011729
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2025
• Device Lot Number: VXFA020622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death; Life Threatening
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Race: White