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

Model Number	VXAK0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Asystole (4442); Heart Block (4444)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient went in heart block.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross connect laac kit was selected for use.The implanting physician obtained access in the left femoral vein and began introducing the versacross rf pigtail wire through a 16fr sheath.Then, the physician followed the wire with the watchman double curve sheath and the versacross connect dilator.While dropping down from the superior vena cava (svc) into the right atrium, the patient went asystolic.Chest compressions were done and patient rhythm returned after three minutes.The patient was in heart block and received a temporary transvenous pacing wire.The patient was hospitalized and later has been discharged, expected to fully recover.The device is not expected to be returned for analysis (disposed).There were no issues noted with transseptal.The patient's ekg prior to implant day suggests that the had some conduction issues (wide qrs).
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.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated field describe event or problem (b5), in section b - adverse event/product prob.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 patient went in heart block.The procedure was cancelled.During a watchman left atrial appendage closure (laac) procedure, a versacross connect laac kit was selected for use.The implanting physician obtained access in the left femoral vein and began introducing the versacross rf pigtail wire through a 16fr sheath.Then, the physician followed the wire with the watchman double curve sheath and the versacross connect dilator.While dropping down from the superior vena cava (svc) into the right atrium, the patient went asystolic.Chest compressions were done and patient rhythm returned after three minutes.The patient was in heart block and received a temporary transvenous pacing wire.The patient was hospitalized and later has been discharged, expected to fully recover.The device is not expected to be returned for analysis (disposed).There were no issues noted with transseptal.The patient's ekg prior to implant day suggests that the had some conduction issues (wide qrs).It was further reported that the procedure did not go according to the plan.Attempted the wm and failed, the versacross wire went the wrong direction.The wire went into the right ventricle briefly after access.This issue was deemed to be not related with transeptal.Transseptal puncture was not achieved.Procedure was aborted not upset.The patient is wearing heart monitor right now.

• 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: 22055365
• Report Number: 2124215-2025-32411
• Device Sequence Number: 12556577
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0007
• Device Catalogue Number: VXAK0007
• Device Lot Number: 0035428435
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 10/21/2024
• 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: Life Threatening; Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Race: White