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

Model Number	VXAK0005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced st elevation leading to air embolism.During a left atrial appendage closure (laac) procedure, a versacross connect laac kit was selected for use.The physician performed transseptal puncture at inferior mid location.The watchman sheath was then advanced, and a watchman device was deployed and implanted successfully.At some point during procedure, there was some visible air on fluoro, but the physician was not sure where it could have come from.The tech flushed the device adequately and it was double checked by physician.It was also confirmed that a wet-to-wet connection was done however the physician is unsure where the air came from.The st elevations were present for a really short period of time, but the patient went back to sinus and was stable at the end of the procedure.The patient is expected to fully recover and was kept for an overnight stay.Patient was stable and later discharged.The device is not expected to be returned for analysis (disposed).A half dose of heparin was given before transseptal puncture (tsp) and half dose after.Patient had pectus excavatum meaning heart was completely rotated, causing transseptal to be difficult.
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 complete unique identifier (udi) and other specific product information.A supplemental report will be filed if the information is received.
Event or Problem Description
It was reported that patient experienced st elevation leading to air embolism.During a left atrial appendage closure (laac) procedure, a versacross connect laac kit was selected for use.The physician performed transseptal puncture at inferior mid location.The watchman sheath was then advanced, and a watchman device was deployed and implanted successfully.At some point during procedure, there was some visible air on fluoro, but the physician was not sure where it could have come from.The tech flushed the device adequately and it was double checked by physician.It was also confirmed that a wet-to-wet connection was done however the physician is unsure where the air came from.The st elevations were present for a really short period of time, but the patient went back to sinus and was stable at the end of the procedure.The patient is expected to fully recover and was kept for an overnight stay.Patient was stable and later discharged.The device is not expected to be returned for analysis (disposed).A half dose of heparin was given before transseptal puncture (tsp) and half dose after.Patient had pectus excavatum meaning heart was completely rotated, causing transseptal to be difficult.It was further confirmed that the patient experienced air embolism that leads to st elevation.
Additional Manufacturer Narrative
The reported allegation remains unverified as the device has not been returned to bsc for analysis and, although the media confirms air present in the system, it was not possible to confirm whether it entered a vein or artery and blocked it.Additionally, a correction to the initial mdr in block describe event or problem (b5), in section b - adverse event/product prob.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 complete unique identifier (udi) and other specific product information.A supplemental report will be filed if the information is received.

• 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): 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: 21860830
• Report Number: 2124215-2025-24408
• Device Sequence Number: 7888430
• Product Code: DRE
• UDI-Device Identifier: 00685447010517
• UDI-Public: (01)00685447010517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/09/2025

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: VXAK0005
• Device Catalogue Number: VXAK0005
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White