MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	VXAK0005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	05/02/2023
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.
Event or Problem Description
It was reported that pericardial effusion (pe) occurred, while using a versacross connect access solution.A left atrial appendage (laa) closure procedure was performed and a 27mm watchman flx closure device was implanted.Approximately 2-3 minutes after release of the closure device, just prior to removing the intracardiac echocardiogram catheter, a 1.2cm pericardial effusion was observed around the pericardium.A pericardiocentesis was performed and 300ml of fluid was drained.The drain was removed and the patient was transferred to the intensive care unit.The patient remained hemodynamically stable throughout the procedure, pericardiocentesis and afterwards.The patient fully recovered and was discharged the following day.Since the drained blood from the pericardiocentesis was dark, the physician suspected that the pe may have originated in the right atrium during the transseptal crossing.The procedure was completed successfully.The physician did not look for an effusion with intracardiac ultrasound prior to the procedure, however a cardiac computed tomography was done the day before that showed no evidence of a pericardial effusion.The physician is not sure when the pericardial effusion occurred.No other devices were used.The patient was not on warfarin and it was not on any antiplatelet drugs.No medical reason was defined for the pericardial effusion.No surgery was performed.The dilator used was versa cross connect.As per the physician, the device suspected to cause the adverse event was the j-wire from the versacross connect kit but he is not convinced.No resistance was felt while maneuvering the transseptal devices.A small collection was noted around the heart and the patient was hemodynically stable throughout.The patient had no fluid around the heart post pericardiocentesis.There was no difficulties during the procedure.There were no difficulties with positioning of the sheath or dilator.It is unknown if other difficulties experiences with the three transseptal punctures.For tenting prior to the radio frequency application, it was 1-2mm of the radio frequency tip was exposed.No issues encountered during transseptal puncture.The location of transseptal puncture was inferior and mid.No difficulties encountered locating the puncture position.There were no issues with visualization.There was no excessive force during transseptal.No difficulties gaining transseptal access.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17026656
• Report Number: 2124215-2023-25905
• Device Sequence Number: 17860543
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220414
• 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): 05/30/2023

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 Expiration Date: 08/03/2025
• Device Model Number: VXAK0005
• Device Lot Number: VMFA240223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WATCHMAN FLX DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Race: White