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

Model Number	VXAK0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Cardiac Tamponade (2226); Pericardial Effusion (3271); Asystole (4442)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an air embolism, st segment elevation occurred and patient experienced cardiac arrest.The procedure was cancelled.During a left atrial appendage (laa) closure procedure, a versacross connect laac was selected for use.The patient had history of renal transplant and esophageal varices.There was a small pericardial effusion present at baseline prior to the case.The physician did not wanted to intubate the patient due to esophageal varices and therefore an intracardiac echocardiography (ice) procedure was done.The ice catheter was inserted without issue.The physician inserted the watchman trusteer access system (was) with the versacross connect and the transseptal puncture was successfully completed.The versacross dilator was then removed but the rf wire remained in the body.Post insertion of the was after the versacross dilator was removed, the patient took a huge breath which resulted in an air embolism in the patient's coronaries.The patient went into asystole and into cardiac arrest.The patients heart was massaged; they were given atropine and a lead was placed to re-activate the heart.The patient was intubated and was going to undergo a computed tomography scan to check for any neurological damage.The patient is recovering from this event.The patient was admitted and remains hospitalized.The device is not expected to be returned for analysis.
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.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.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.

• 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 Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23477692
• Report Number: 2124215-2025-79781
• Device Sequence Number: 18724441
• Product Code: DRE
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: VXAK0007
• Device Catalogue Number: VXAK0007
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/05/2025
• 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; Life Threatening; Hospitalization
• Patient Sex: Unknown