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

Model Number	VXAK0007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	07/24/2025
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 a pericardial effusion occurred.During a left atrial appendage closure (laac) procedure, a versacross connect laac was selected for use.The patient had a pacemaker and history of von willebrand disease.The transeptal puncture (tsp) was completed in an inferior/mid location on the fossa using intracardiac echo (ice) guidance.The physician had challenges getting the versacross wire past the pacer leads and had to redirect several times.After getting across to left side, the 27mm watchman delivery system (wds) was advanced and deployed.It was noted that the wds was too small and had low compression.The wds was removed and replaced with a larger 31mm watchman flx pro device.The 31mm wds met position, anchor, size and seal (pass) criteria and the 31mm closure device released.A pericardial effusion sweep was performed before the procedure, several times during and after implant procedure with no findings.It was reported that after the patient was returned to post-op care area, the patient blood pressure was observed to be notably lower.The anesthesiologist performed a limited echo and no pericardial effusion was seen.Per the anesthesiologist, albumin and fluids were administered and the patient vitals temporarily returned to normal.About 15-20 minutes later the patient blood pressure softened and another echo was performed.At this time a moderate effusion was seen on imaging.The patient was taken to the cath lab where about 400ml of blood was removed to treat the effusion.The patient was taken to the intensive care unit (icu) once stabilized and monitored overnight.The following morning, the drain was removed from patient's chest.Per implanter, the patient was doing well and was discharged as planned.The device is not expected to be returned for analysis (disposed).

• 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; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22798357
• Report Number: 2124215-2025-56604
• Device Sequence Number: 15525453
• 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): 08/13/2025

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: 0035221605
• 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
• Initial Report FDA Received Date: 08/13/2025
• Date Device Manufactured: 08/30/2024
• 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: 79 YR
• Patient Sex: Female