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

Model Number	VXSK0021
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
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 access solution was selected for use during an atrial fibrillation (a fib).During the procedure, it was noted that the versacross kit was received with no label on the inner package (pouch).Thus, the kit was not used, and it was replaced.No patient complications were reported.The procedure was completed successfully.The product will return for analysis.
Event or Problem Description
It was reported that a versacross access solution was selected for use during an atrial fibrillation (a fib).During the procedure, it was noted that the versacross kit was received with no label on the inner package (pouch).Thus, the kit was not used, and it was replaced.No patient complications were reported.The procedure was completed successfully.The product will return for analysis.
Additional Manufacturer Narrative
The returned versacross access solution has been received.On 12jul2023, the investigation was concluded.During inspection, no damage was identified in the packaging, including the shelf box and pouch.The seals on the pouch were intact, and no sterile breaches were detected.The devices themselves were also found to be undamaged.The shelf box label accurately provided the correct information and was in alignment with the device history review.However, the issue has been confirmed, since it was noted that the pouch label did not match the designated pouch.

• 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: 17082907
• Report Number: 2124215-2023-28385
• Device Sequence Number: 6273438
• Product Code: DYB
• UDI-Device Identifier: 00685447011729
• UDI-Public: 00685447011729
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,Followup
• Report Date (Section B): 08/08/2023

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: 01/31/2026
• Device Model Number: VXSK0021
• Device Lot Number: VXFA010323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown