MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS LARGE ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VLAK0114
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	07/29/2025
Type of Reportable Event	Death
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.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained yet.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a patient death occurred.During a concomitant pulse field ablation procedure, a versacross large access was selected for use.A baseline effusion was noted prior to transseptal.Once groin access was obtained, there was difficulty ascending the femoral vein and crossing transeptal.Transeptal was sudden and visibility was poor.The physician flossed with the versacross large access.However, the faradrive sheath could not go across.So, it was attempted with the faradrive dilator and trusteer dilator, then was able to cross with faradrive.The pressure dropped a few times at transeptal during flossing.The pressure was treated.The physician used intracardiac echocardiography (ice) to watch for effusion while ablation.It started growing when ablating right veins.A pericardiocentesis was done after finishing ablation.One liter was drawn and patient was stabilized.Later, the patient passed away in the intensive care unit (icu) from complications.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated fields initial reporter title, initial reporter first name, initial reporter last name, initial reporter facility name, initial reporter address 1, initial reporter city, initial reporter state, initial reporter zip/post code, initial reporter phone (e1), and health professional? (e2) and occupation (e3), in section e - initial reporter.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.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a patient death occurred.During a concomitant pulse field ablation procedure, a versacross large access was selected for use.A baseline effusion was noted prior to transseptal.Once groin access was obtained, there was difficulty ascending the femoral vein and crossing transeptal.Transeptal was sudden and visibility was poor.The physician flossed with the versacross large access.However, the faradrive sheath could not go across.So, it was attempted with the faradrive dilator and trusteer dilator, then was able to cross with faradrive.The pressure dropped a few times at transeptal during flossing.The pressure was treated.The physician used intracardiac echocardiography (ice) to watch for effusion while ablation.It started growing when ablating right veins.A pericardiocentesis was done after finishing ablation.One liter was drawn and patient was stabilized.Later, the patient passed away in the intensive care unit (icu) from complications.The device is not expected to be returned for analysis (disposed).

• Brand Name: VERSACROSS LARGE ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICALE CIE INC; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22832497
• Report Number: 2124215-2025-57545
• Device Sequence Number: 21226170
• Product Code: DRE
• UDI-Device Identifier: 00685447019596
• UDI-Public: (01)00685447019596(17)280206(10)36400949
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201288
• 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,Followup
• Report Date (Section B): 09/15/2025

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: VLAK0114
• Device Catalogue Number: VLAK0114
• Device Lot Number: 0036400949
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female