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

Model Number	VSTK0003
Medical Device Problem Codes	Material Frayed (1262); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a versacross steerable access solution was selected for use during an amulet laac - left atrium appendage closure.It was difficult going transeptal, since the rf button was pushed four times and the transseptal was unsuccessful.On the 4th attempt they were able to go transeptal.However, when the physician advanced the rf wire, he noticed that it looked odd on fluoro so they exchanged for a non boston scientific wire.Once removed completely from the patient's body, it was noticed that the rf wire was frayed and separated into two pieces.The physician had some difficulty catching on the sheath upon removal of the rf wire due to fraying, but not much.No patient complications were reported.The procedure was completed successfully.The device is not expected to be returned for analysis.
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 that a versacross steerable access solution was selected for use during an amulet laac - left atrium appendage closure.It was difficult going transeptal, since the rf button was pushed four times and the transseptal was unsuccessful.On the 4th attempt they were able to go transeptal.However, when the physician advanced the rf wire, he noticed that it looked odd on fluoro so they exchanged for a non boston scientific wire.Once removed completely from the patient's body, it was noticed that the rf wire was frayed and separated into two pieces.The physician had some difficulty catching on the sheath upon removal of the rf wire due to fraying, but not much.No patient complications were reported.The procedure was completed successfully.The device is not expected to be returned for analysis.It was further reported that the devices were advanced up to superior vena cvc, retract rf wire through dilator in svc, and drop down onto the septum, and no additional exchanges completed prior to attempting tsp.After tsp was made and the appearance of the versacross rf wire was not normal and the physician changed for a non-boston scientific wire.The wire was not inserted through an introducer needle.The wire was front loaded.No other issues were noted.
Additional Manufacturer Narrative
Additional information added to fields b5 'describe event or problem".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 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: 17306389
• Report Number: 2124215-2023-36258
• Device Sequence Number: 17768751
• Product Code: DXF
• UDI-Device Identifier: 00685447011941
• UDI-Public: 00685447011941
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2025
• Device Model Number: VSTK0003
• Device Lot Number: VKFB190123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown