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

Lot Number	VMFC191223
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Hematoma (1884); Swelling/ Edema (4577)
Date of Event	02/15/2024
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
It was reported a hematoma/swelling/edema occurred.During the watchman procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.The physician was performing the transseptal puncture (tsp) positioning at mid-inferior and mid on the fossa.When radio frequency (rf) was delivered, the physician thought that the rf wire was still in the dilator.The transesophageal echocardiogram (tee) probe was obstructing the view of the dilator tip so its probe was moved a bit and the rf was delivered again.The physician did not realize that the connect device could have moved from the time of the initial rf to the time the actually went across.After the watchman device was released, the tee physician noticed a hematoma/swelling around the non-coronary cusp of the aortic root which was not present prior to the procedure.The shunting of the transseptal puncture was observed and it was noted very anterior, almost right next to the aorta.The cardiac surgeon was called and aortogram computed tomography (cta) was requested.The patient was kept hospitalized for monitoring.The cta results were normal, the patient remained stable (current status unknown) and will have a repeat cta done.The device is not expected to be returned for analysis (discarded).

• 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, qc 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: 18899865
• Report Number: 2124215-2024-15207
• Device Sequence Number: 13045328
• Product Code: DRE
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/13/2024

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: 09/21/2026
• Device Lot Number: VMFC191223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: White