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

Model Number	VSTK0016
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pro code (product code): d2b, dxf and dyb.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the sheath exhibited a sheath leak and a tear in the hemostatic valve.During an ablation procedure to treat atrial fibrillation (a fib) a versacross steerable access solution sheath was selected for use.The sheath exhibited a hemostatic valve leak.The leak was a slow drip of saline with not a lot of blood present.Backloading the dilator into the sheath may have torn the hemostatic valve.The sheath was replaced with another of the same model.The procedure was completed with no patient complications.The device is expected to be returned for analysis.
Event or Problem Description
It was reported that the sheath exhibited a sheath leak and a tear in the hemostatic valve.During an ablation procedure to treat atrial fibrillation (a fib) a versacross steerable access solution sheath was selected for use.The sheath exhibited a hemostatic valve leak.The leak was a slow drip of saline with not a lot of blood present.Backloading the dilator into the sheath may have torn the hemostatic valve.The sheath was replaced with another of the same model.The procedure was completed with no patient complications.The device has been returned for analysis.
Additional Manufacturer Narrative
The versacross steerable access solution sheath was returned to boston scientific for analysis.Upon receipt at our post market quality assurance laboratory the sheath underwent a visual inspection, vhx testing, and leakage testing.Prior to decontamination, the sheath and dilator were visually inspected, and blood was observed in the sideport tubing.The sheath valve was inspected under magnification, which revealed dried blood outside the valve and valve damage.The hemostasis valve air and liquid leakage tests were then performed, and in all tests, the required pressure could not be met due to either water leaking through the valve or air bubbles entering through the valve.The reported clinical observations of leaking and valve damage were confirmed by analysis, though the sheath/dilator interaction allegation was not confirmed.

• Brand Name: VERSACROSS STEERABLE 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: 16655439
• Report Number: 2124215-2023-11731
• Device Sequence Number: 17742178
• Product Code: DYB
• UDI-Device Identifier: 00685447012078
• UDI-Public: 00685447012078
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190688
• 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): 07/13/2023
• 2 Devices were Involved in the Event: 1 2

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: 03/21/2025
• Device Model Number: VSTK0016
• Device Lot Number: VKFG170622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown