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

Model Number	VXAK0101
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was noted a cardiac tamponade and pericardial effusion (pe) occurred.During a left atrial appendage (laa) closure procedure, a versacross connect laac was selected for use.Intracardiac echocardiogram (ice) imaging was being used and confirmed there was not a pre-existing effusion present.Venous access was obtained and transseptal puncture (tsp) was performed.There was difficulty visualizing the wire on ice.The wire was tenting.Difficulty of ra anatomy not so much tsp workflow.After tsp, a small pe became visible on ice, and the physician determined this was due to ice catheter manipulation during tsp.The patient remained stable.A watchman flx pro delivery system and closure device (wds) was inserted and the closure device was implanted in the left atrial appendage (laa).After release of the closure device, hypotension was noted.An effusion sweep was performed and a noticeably larger pe was present at the ventricles in the pericardium.A pericardiocentesis was performed, with 185cc of fluid removed.Pericardial drain and chest tube was place.The procedure was concluded.The patient was admitted to the coronary care unit (ccu) for overnight observation and three units of blood given to patient.The patient was hospitalized as of (b)(6) 2025.The device is not expected to be returned for analysis (disposed).The physician does not believe that access solutions contributed to the patient complication.
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.
Additional Manufacturer Narrative
Due to additional information received, this follow-up 1 report is being submitted for the updated field describe event or problem (b5), in section b: adverse event or product problem.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.
Event or Problem Description
It was noted a cardiac tamponade and pericardial effusion (pe) occurred.During a left atrial appendage (laa) closure procedure, a versacross connect laac was selected for use.Intracardiac echocardiogram (ice) imaging was being used and confirmed there was not a pre-existing effusion present.Venous access was obtained and transseptal puncture (tsp) was performed.There was difficulty visualizing the wire on ice.The wire was tenting.Difficulty of ra anatomy not so much tsp workflow.After tsp, a small pe became visible on ice, and the physician determined this was due to ice catheter manipulation during tsp.The patient remained stable.A watchman flx pro delivery system and closure device (wds) was inserted and the closure device was implanted in the left atrial appendage (laa).After release of the closure device, hypotension was noted.An effusion sweep was performed and a noticeably larger pe was present at the ventricles in the pericardium.A pericardiocentesis was performed, with 185cc of fluid removed.Pericardial drain and chest tube was place.The procedure was concluded.The patient was admitted to the coronary care unit (ccu) for overnight observation and three units of blood given to patient.The patient was hospitalized as of (b)(6) 2025.The device is not expected to be returned for analysis (disposed).The physician does not believe that access solutions contributed to the patient complication.It was further confirmed that the patient has been discharged.

• Brand Name: VERSACROSS CONNECT LAAC 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: 22796848
• Report Number: 2124215-2025-56480
• Device Sequence Number: 8789339
• Product Code: DXF
• UDI-Device Identifier: 00685447019466
• UDI-Public: (01)00685447019466
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: VXAK0101
• Device Catalogue Number: VXAK0101
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/04/2025
• 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: 72 YR
• Patient Sex: Unknown
• Patient Race: Black Or African American