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

Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/09/2024
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
A perforation and a pericardial effusion (pe) were reported.It has been reported that a versacross connect access solution kit was selected for use for a watchman left atrial appendage closure procedure.Post procedure, approximately 30 minutes after successful watchman deployment, the patient became hypotensive.Upon further examination, a perforation was discovered in the left atrium (la).Thus, a pericardiocentesis was performed to manage the effusion, followed by cardiothoracic (ct) surgical intervention.Patient was admitted to the hospital beyond standard of care, and it was later discharged.The product is not expected to return for analysis (disposed).It was also reported that multiple attempts required to track up / drop down into position on septum before tsp since the septum was extremely aneurysmal so it took some time to find the spot to cross.Due to the same reason, tenting was very heavy, thus extra caution was taken during the transseptal.Likely perforation occurred during this portion of the case since it was close to back wall during tenting.Two applications of radio frequency were needed, since it was not possible to cross in the first time.There is a potential reason to believe that the versacross rf wire malfunctioned during the procedure.Also, in the physician's opinion, the dilator did not malfunction or contribute to the ae.However, in the physician's opinion, the la was perforated during transseptal puncture, but it went unnoticed at the time and the watchman device was still places successfully.Prior to the procedure, no pe was noted on the echocardiogram.The patient was not under warfarin at the time.

• 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: 19498660
• Report Number: 2124215-2024-35188
• Device Sequence Number: 17805432
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/10/2024

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: 05/18/2024
• Initial Report FDA Received Date: 06/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Female