MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Model Number	VXSK0122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Tachycardia (2095); Cardiac Perforation (2513); Pericardial Effusion (3271); Asystole (4442)
Date of Event	05/09/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported a patient death occurred.During a pulmonary vein isolation ablation procedure, a versacross access solution kit was selected for use.The physician obtained access in both right and left femoral vein.Intracardiac echocardiography (ice) imagining was inserted in left femoral vein.The guidewire was advanced to superior vena cava (svc) and then the versacross transseptal sheath as well as the rf wire.The transseptal puncture (tsp) and the rf wire were advanced in the left atrium.There was no difficulty noted with the tsp workflow.The patient had an increased heart rate of 215 bpm that sustained for a minute.Then pericardial effusion (pe) was noted on ice imaging and a pericardiocentesis began.Cardiopulmonary resuscitation (cpr) was started and code blue alarm was called.The patient was asystole.The physician opened patient chest, and blood transfusion began.Cardiac message was performed.Sodium bicarb was given through the sheath.Vasopressors given by ic physician.Aortic cannulation was administered and venous perfusion began.The bypass surgery was initiated.A 90 volt shock administered to heart, however later the patient was declared dead.The autopsy has not been performed yet however it is expected that death was caused by complications due to perforation of cardiac tissue.The device is not expected to be returned for analysis (disposed).The official cause of death was pericardial effusion.The patient had a small left atrium.There are no pre-existing patient conditions that may have caused a complication during the procedure.Medwatch reference mw5170596.It was additionally reported that it was pulled out over a liter of fluid.The patient continued to bleed.When the patient's chest was opened up and it was noticed one perforation in the right ventricle (rv) that they believed may have been caused by the tap for the pericardiocentesis.The left appendage had a couple of perforations as well that they believe was from the dilator.The caller stated they assumed the faradrive catheter and the versacross wire were the cause of the injury.Faradrive sheath and a boston coronary sinus (cs) were in the body when the event occurred.The caller stated they believe the faradrive dilator perforated the left appendage while going transseptal.
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 MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22123765
• Report Number: 2124215-2025-35479
• Device Sequence Number: 8841510
• Product Code: DXF
• UDI-Device Identifier: 00685447019824
• UDI-Public: (01)00685447019824(17)280108(10)36004282
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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 Model Number: VXSK0122
• Device Catalogue Number: VXSK0122
• Device Lot Number: 0036004282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 01/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Race: White