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); Difficult to Advance (2920)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
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.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.
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 kit was selected for use.The patient anatomy was challenging to visualize on transesophageal echocardiogram (tee) due to the patient having a septal occluder.The physician was made aware that this was a contraindication of the procedure and the decision was made to proceed.Intracardiac echocardiography (ice) was inserted to obtain other views of the septum.The anatomy was challenging to see but views of the inferior/superior portion was visualized.The transseptal puncture was attempted but felt resistance upon advancement of the pigtail wire.It was unable to visualize the wire in the left atrium, the physician removed the wire back into the trusteer and versacross connect dilator.The physicians checked for effusion before continuing and found a small collection of fluid 'on the posterior portion of the heart' which 'appeared to loculated and localized'.The patient was monitored for several minutes while cv surgery was consulted.The decision was made to admit the patient and monitor over night as she was stable and had not had any hemodynamic changes.There was a follow up echo ordered.The device is not expected to be returned for analysis (disposed).The patient had no further accumulation upon the second echo.The physician was not able to visualize the pigtail wire across the septum however, there were bubbles seen in the left atrium after energy was delivered.Visualization was challenging for the tenting of the septum.Cv surgery was called and consulted with no interventions were needed.Patient was admitted over night for observation.The act was 274.

• 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): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21998600
• Report Number: 2124215-2025-29947
• Device Sequence Number: 18326357
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 05/09/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VXAK0007
• Device Catalogue Number: VXAK0007
• Device Lot Number: 0034767516
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/09/2025
• Date Device Manufactured: 05/06/2024
• 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; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: White