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

Model Number	VXSK0031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
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 access solution kit was selected for use during a left atrium appendage closure (watchman) to treat a stroke prevention for fibrillation.During the preparation for the procedure, upon opening the package, it was noticed a fracture on the mechanical guidewire component of the versacross kit, as the physician was prepping to insert via the versacross sheath.The device was not broken completely in two pieces.It is unsure if the stretch, that was not mentioned by the physician.No damage to the package was noted.No patient complications were reported.The procedure was completed successfully.

• Brand Name: VERSACROSS 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: 17088742
• Report Number: 2124215-2023-27796
• Device Sequence Number: 6172813
• Product Code: DYB
• UDI-Device Identifier: 00685447011828
• UDI-Public: 00685447011828
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 06/08/2023

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: 09/27/2025
• Device Model Number: VXSK0031
• Device Lot Number: VXFK190123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/08/2023
• 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