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

Model Number	VXAK0007
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman procedure, a versacross connect laac access solution was selected for use.A trace effusion was noted at the start of the case.While trying to go transeptal which appeared to be at mid/mid on the septum.Transesophageal echocardiogram (tee) imaging was very difficult to go off of.When buzzed across there were no bubbles in the left atrium and the wire was not seen in the left atrium.A pericardial effusion check on tee was performed, and at that time the echo cardiologist noticed the effusion went from trace to small.Pressures remained stable but there was a change in the size of the effusion.Protamine was given and continued monitoring the patient.About ten minutes later the pressures slightly dropped and the effusion had gotten a little larger.A pericardiocentesis was performed and 200cc of blood was removed.Patient is currently stable.The device is not expected to be returned for analysis (disposed).
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.
Event or Problem Description
It was reported that a pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman procedure, a versacross connect laac access solution was selected for use.A trace effusion was noted at the start of the case.While trying to go transeptal which appeared to be at mid/mid on the septum.Transesophageal echocardiogram (tee) imaging was very difficult to go off of.When buzzed across there were no bubbles in the left atrium and the wire was not seen in the left atrium.A pericardial effusion check on tee was performed, and at that time the echo cardiologist noticed the effusion went from trace to small.Pressures remained stable but there was a change in the size of the effusion.Protamine was given and continued monitoring the patient.About ten minutes later the pressures slightly dropped and the effusion had gotten a little larger.A pericardiocentesis was performed and 200cc of blood was removed.Patient is currently stable.The device is not expected to be returned for analysis (disposed).
Additional Manufacturer Narrative
Correction to the initial mdr in block(s) init rptr also sent rep to fda (e4), in section e - initial reporter, impact codes (f10 and h6), in sections f -for use by uf/importer and h - device manufacturers only, and mfr site facility name, mfr site address 1, mfr site city, mfr site zip/post code, mfr site country (g1), in section g - all manufacturers.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.

• 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: 22153657
• Report Number: 2124215-2025-37025
• Device Sequence Number: 9263106
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/03/2025

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: 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: 05/16/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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
• Patient Age: 81 YR
• Patient Sex: Female