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

Lot Number	VKFE191223
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a versacross steerable access solution kit was selected for use.Upon opening the package, a leak was noted in one of the devices.Hence, the procedure was completed using another device.No patient complications occurred.The device is expected to be returned for analysis.No other issues were reported.
Event or Problem Description
It was reported that a versacross steerable access solution kit was selected for use.Upon opening the package, a leak was noted in one of the devices.Hence, the procedure was completed using another device.No patient complications occurred.The device is expected to be returned for analysis.No other issues were reported.
Additional Manufacturer Narrative
The returned versacross sheath and dilator were analyzed, passed all tests performed, and exhibited normal device characteristics.The sheath did not show any signs of air or liquid leakage.Therefore, the reported event was not confirmed.Upon receipt at our post market quality assurance laboratory, the versacross sheath and dilator were first visually inspected, and it passed flushing test (pre and pot decontamination), no leakage noted, nor visible damage seen on the devices.Next, on the vxh testing, no physical damages were noted that would suggest the possibility of leakage, and no damage to the tip of the dilator.The tubing appears to be stretched, but intact, and there is no evidence of damage that would cause leakage.Finally, the devices passed the leakage testing; the required test conditions and final pressures could be met, which concluded that there was no problem detected with the sheath.The potential root cause could be aggressive handling technique when manipulating/inserting/removing the ancillary device from the sheath.Another potential root cause includes improper locking of the stopcock leur.

• 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19505237
• Report Number: 2124215-2024-35282
• Device Sequence Number: 17161771
• Product Code: DYB
• UDI-Device Identifier: 00685447012122
• UDI-Public: 00685447012122
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: 05/30/2026
• Device Lot Number: VKFE191223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown