MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A perforation leading to a pericardial effusion (pe) occurred and the procedure was cancelled.During a watchman flx procedure, a versacross connect access solution kit was selected for use.The physician reporte that post-transeptal puncture there was a changed in hemodynamics.Transesophageal echocardiography (tee) showed fluid buildup in the pericardial space.The patient was then treated with anesthesia, a pericardiocentesis tray to aspirate the fluid, and a blood transfusion.It is believed the pe was caused by a perforation to the posterior wall.Procedure was cancelled, the patient admitted to hospital beyond standard of care, was was stable leaving the room and is expected to fully recover.The device is not expected to be returned for analysis (disposed).Prior to the procedure, no pe was noted.The patient was not on warfarin or any antiplatelet drugs at the time of the procedure.The physician has difficulties visualizing the ias on ice and tee, but the versacross rf wire was visible.In the physician's opinion, neither the versacross dilator nor rf wire malfunctioned in the procedure, but the location of transseptal may have contributed to puncture of wall of left atrium.
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.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19960464
• Report Number: 2124215-2024-49851
• Device Sequence Number: 8618894
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• 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): 08/12/2024

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
• 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: 07/23/2024
• Initial Report FDA Received Date: 08/12/2024
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Female