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

Lot Number	VMFB020124
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that a versacross connect access solution kit was selected for use for watchman left atrial appendage closure (laac) procedure.A perforation and a pericardial effusion (pe) occurred.The procedure was cancelled.During the procedure, while attempting to go for transseptal puncture using intracardiac echocardiography (ice) imaging, a perforation occurred, and it was noticed a pericardial effusion that was not present at the beginning of the case.Protamine was given to manage the effusion, and therefore the procedure was cancelled.The issue occurred prior to transseptal.Patient was admitted to an overnight stay, and it was discharged.The device is not expected to be returned for analysis.No pe was noted on the echo prior to the procedure.The patient was not on warfarin or antiplatelet drugs at the time of procedure.It has been further mentioned that multiple attempts were required to track up and down towards the septum.The act was therapeutic during the procedure.In the physician's opinion, the versacross wire and dilator did not malfunction during the procedure, and it is not believe the versacross dilator contributed to the ae, rather the ice catheter.No other issues were reported.
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: 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: 19115873
• Report Number: 2124215-2024-22880
• Device Sequence Number: 7102823
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/16/2024

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
• Device Expiration Date: 09/26/2026
• Device Lot Number: VMFB020124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Race: White