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

Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Hematoma (1884); Cardiac Perforation (2513)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that a versacross access solution kit was selected for use for a watchman left atrial appendage closure procedure.A perforation and an aortic hematoma occurred, and the procedure was cancelled.During the procedure, the physician mentioned that they were experiencing difficulties visualizing the versacross connect system due to the leads that were present in the right atrium.Since it was not possible to achieve their desired location with the versacross connect system, these devices where swapped it out for the versacross access kit.Thus, with it, it was possible to visualize tenting at a mid/slightly anterior point.Radio frequency (rf) was then applied, and it did not appear that it crossed, so rf was applied a second time, and yet still unsuccessful crossing.Once preparing for the third attempt, while checking back to the short axis to make sure it was still a good spot, it was discovered that the patient developed an aortic hematoma.No change in effusion size was noted to the initially noted trace effusion prior to procedure.Patient was stable during the entire time.No interventions were required.The patient was sent for a computed tomography (ct) and nothing more was found.Patient was discharge from the hospital (date unknown).The devices are not expected to be returned for analysis.There were multiple attempts were required to track up and down towards the septum.It was also confirmed that a perforation occurred but unsure of the exact location.No other issue was 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 ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• 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: 19038331
• Report Number: 2124215-2024-20377
• Device Sequence Number: 20874818
• Product Code: DYB
• UDI-Device Identifier: 00685447011835
• UDI-Public: 00685447011835
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 04/03/2024

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): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Race: White