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

Model Number	VXSK0022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	03/10/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported a patient death occurred.The procedure was cancelled.During an atrial fibrillation ablation procedure, versacross access solution kit was selected for use.The cti line was performed in the right atrium using a non-boston scientific mapping catheter.After the cti line was performed, the physician performed transeptal puncture with no issues reported.Once across the septum, the versacross sheath was exchanged for the faradrive sheath and the mapping catheter was inserted.It was at this point that the patient's heart rate became tachycardic and hypotensive with only an available reading of map of 24.The blood pressure was then reattempted with a systolic in the 60's.The patient's heart rate then declined to the 50's-40's where they were then pulseless electrical activity (pea) and required resuscitative efforts.An intracardiac echocardiography (ice) scan detected a pericardial effusion which led to cardiac tamponade.A pericardiocentesis was performed and blood was administered.The patient passed away despite the efforts of the lab staff.The device is expected to be returned for analysis.The pericardial effusion was noted on ice image, but unsure of exactly where is started.It was reported that the patient was elderly and was in persistent atrial fibrillation (a fib) for along period of time, anatomy could have been a factor.The physician did not make any comments that our device was the cause of the incident.

• 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: 21699984
• Report Number: 2124215-2025-18769
• Device Sequence Number: 8635968
• Product Code: DXF
• UDI-Device Identifier: 00685447007432
• UDI-Public: 00685447007432
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/26/2025

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: VXSK0022
• Device Catalogue Number: VXSK0022
• Device Lot Number: 0035552652
• 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: 03/10/2025
• Initial Report FDA Received Date: 03/26/2025
• Date Device Manufactured: 10/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown