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

Model Number	VXAK0045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
A perforation and pericardial effusion (pe) has occurred.It was reported that a versacross connect access solution for faradrive was selected for use a pfa procedure.Before ablation, it was found that the patient had a baseline effusion.The cti was ablated with the farawave catheter off-labeled, without complications.Then, the physician performed a transseptal puncture and advanced the catheter into the left atrium to complete the pulmonary vein isolation successfully.After completing the ablation, the physician looked at the existing effusion and noticed that it was increasing (posterior).A pericardiocentesis was performed and a drain was placed.The patient was hospitalized beyond standard of care and was doing well and getting their chest tube removed sometime on the last week of october.The device is not expected to return as it was disposed.In the physician's opinion, any of the bostin scientific products used during the procedure contributed to this adverse event.A perforation had happened.No other issues were reported.

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20589206
• Report Number: 2124215-2024-68748
• Device Sequence Number: 18339950
• Product Code: DXF
• UDI-Device Identifier: 00685447019060
• UDI-Public: 00685447019060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/01/2024

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 Model Number: VXAK0045
• Device Catalogue Number: VXAK0045
• Device Lot Number: 0034857560
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/01/2024
• Date Device Manufactured: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female