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	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/28/2024
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
It was reported a pericardial effusion (pe) occurred and the procedure was cancelled.During a pulse field ablation procedure for an atrial fibrillation case, a versacross access solution kit was selected for use.The physician attempted transseptal puncture to the left atrium, however felt uncomfortable with the positioning but proceeded.After the transseptal was performed, there was a sudden drop in patient blood pressured noted.The intracardiac echocardiography (ice) images review began and a pe was noted.A pericardiocentesis was performed.The patient was admitted to hospital beyond standard of care.The device is not expected to be returned for analysis.The physician was aware that the puncture site was probably going to be too superior to what is recommended and proceeded.There is no reason to believe that the device malfunctioned and caused the effusion.The activated clotting time (act) was not at therapeutic levels because the physician does not administer the heparin until after the transseptal puncture has occurred and until the wire in the left atrium.There was no difficulty maneuvering the sheath.The location of the perforation could not be located with ice or with transthoracic echocardiogram (tte) once echo arrived.The patient was taken to the operating room (or) just as a precaution to treat perforation if located.The patient was stable upon transfer to the or.This was the patient second ablation for atrial fibrillation and had a prior cryo ablation with a prior transseptal puncture roughly a year ago.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20693909
• Report Number: 2124215-2024-71788
• Device Sequence Number: 18288669
• Product Code: DXF
• UDI-Device Identifier: 00685447007432
• UDI-Public: 00685447007432
• 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): 11/15/2024

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: VXSK0022
• Device Catalogue Number: VXSK0022
• Device Lot Number: 0034747175
• 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: 10/28/2024
• Initial Report FDA Received Date: 11/15/2024
• Date Device Manufactured: 07/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown