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

Model Number	VSTK0021
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	06/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a watchman procedure to treat atrial fibrillation (a fib) in left atrial appendage (laa), a versacross connect solution was selected for use and perforation happened on the right side of the heart while attempting to go transseptal.There was a baseline trace effusion when we started.Just a normal amount of fluid in the pericardial space.The patient had a lipomatous septum (superiorly) and a large eustachian valve that kept pushing the transseptal system off (watchman fxd double curve and versacross connect).Hence in order to attempt to get and maintain contact with the fossa ovalis, a versacross steerable was opened to try to get transseptal.It made contact with the septum inferiorly and posteriorly on transesophageal echocardiogram (tee) and radio frequency was not applied and hence never crossed the septum.Approximately 10 minutes after inserting the steerable versacross, the patient's pressure dropped and a pericardial effusion was noted on the echo.A drain was placed and patient was taken to the operation room (or) where a sternotomy with a repair and a left atrial appendage ligation was performed.The surgeon noted a 4mm hole in a the transverse sinus between the two atria when he performed the sternotomy.Patient was admitted to hospital beyond standard of care and expected to fully recover.The device is not expected to be returned for analysis as it was disposed.
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 STEERABLE ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• 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: 17305749
• Report Number: 2124215-2023-36063
• Device Sequence Number: 7223856
• Product Code: DXF
• UDI-Device Identifier: 00685447012122
• UDI-Public: 00685447012122
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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): 07/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2025
• Device Model Number: VSTK0021
• Device Lot Number: VKFD160323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female