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

Model Number	VXAK0007
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a pericardial effusion (pe) occurred.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross connect laac kit was selected for use.Pre-imaging showed trace effusion prior to procedure.The physician obtained groin access and the first versacross connect system was inserted up to superior vena cava (svc).The physician complained of difficulties retracting the rf wire from the dilator, thus both the wire and dilator were removed and replaced with a new a versacross connect system.The physician went up to the svc with the wire several times and attempted to drop down to the fossa getting inferior on the septum.The septum was very aneurysmal and each time the physician dropped down to the inferior vena cava (ivc), the versacross system fell off and rewire was done again to get to the svc.After several reshaping of the versacross connect and advancement to the svc and falling off inferior, the patient started to develop a larger circumferential effusion at 1.07 centimeters.The physician decided to intervene by performing a pericardial tap and removed 500cc of fluid off the pericardium.The patient remained hemodynamically stable and was sent to the intensive care unit.The first rf wire is expected to be returned for analysis.The devices from the new kit were disposed.Heparin was given and the patient was therapeutic.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.A separate report for the devices related to the second versacross kit will be submitted.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.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.

• 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: 22088829
• Report Number: 2124215-2025-34253
• Device Sequence Number: 6926615
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/27/2025

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: 0035358841
• 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: 05/07/2025
• Initial Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 10/03/2024
• 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; Life Threatening; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White