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

Model Number	VXAK0101
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a pericardial effusion.The procedure was cancelled.During a left atrial appendage (laa) closure procedure was being performed, a versacross connect laac was selected for use.The physician gained access to the patient and then inserted the versacross connect along with the watchman sheath.The physician made several attempts at performing the transseptal puncture but was not successful, due to anatomy and length of reaching septum.Intracardiac echocardiography (ice) imaging showed that there was a pericardial effusion in the right ventricle.The procedure was aborted and the patient was monitored.Four (4) hours post procedure transthoracic echocardiogram imaging showed that the pericardial effusion had resolved.The patient remained in the hospital overnight for observation and was discharged home the next day fully recovered from this event.The device is not expected to be returned for analysis (disposed).No pericardial effusion was noted on the echo before the procedure.The patient was not under warfarin at the time, nor antiplatelet drugs.No radio frequency was applied with versacross rf wire.The physician just had problems reaching and staying in contact with the septum due to patient anatomy.Patient remained hemodynamically stable.
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.

• Brand Name: VERSACROSS CONNECT LAAC 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; 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: 22362317
• Report Number: 2124215-2025-43226
• Device Sequence Number: 8430142
• Product Code: DRE
• UDI-Device Identifier: 00685447019466
• UDI-Public: (01)00685447019466(17)280116(10)35807053
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 06/30/2025

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: VXAK0101
• Device Catalogue Number: VXAK0101
• Device Lot Number: 0035807053
• 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: 06/10/2025
• Initial Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Unknown