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

Model Number	VSTK0122
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cardiac perforation and pericardial effusion (pe) occurred.The procedure was cancelled.During a atrial fibrillation ablation (pulmonary vein isolation) redo procedure, a versacross steerable access solution was selected for use.During transseptal, there were five (5) attempts were made using radio frequency at one second constant setting to cross the septum.This was unsuccessful.A pericardial effusion was noted immediately and the physician performed an emergency pericardiocentesis.A 500 ml of bright blood was removed from the pericardium.The patient was not in cardiac arrest.Once stabilized, the patient was extubated and transferred to the cardiac intensive care unit with a pericardial drain.The following day, the drain was removed and follow-up echocardiogram was stable.The patient was discharged home and ablation procedure will be rescheduled.The device is not expected to be returned for analysis (disposed).In the physician's opinion, the access solution devices did not contributed to the patient complications.
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.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was not available.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.

• Brand Name: VERSACROSS STEERABLE 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22841675
• Report Number: 2124215-2025-57849
• Device Sequence Number: 18507560
• Product Code: DXF
• UDI-Device Identifier: 00685447019718
• UDI-Public: (01)00685447019718
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VSTK0122
• Device Catalogue Number: VSTK0122
• 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: 07/30/2025
• Initial Report FDA Received Date: 08/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown