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

Model Number	VXSK0021
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event has been populated with the first day of february as an approximate, since only the bsc aware date has been provided, no event date is available.Field d2b.Pro code (product code): dxf, 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 during a procedure, a versacross sheath was selected for use.During the procedure it was difficult to cross the septum.No further details were reported.No patient complications were reported.The lot number provided could not be populated in the system.
Additional Manufacturer Narrative
The returned versacross access solution was analyzed, passed all tests performed, and exhibited normal device characteristics.He reported allegation is not confirmed.Testing and analysis of the returned sheath and dilator did not provide substantial evidence of causing difficulty advancing the device through the septum.The investigation conclusion code, cause not established was selected based on the information provided within the event description and the results obtained during investigation of the returned product.Cause not established is supported by the following objective evidence: in house inspection during manufacturing confirms that all sheath tips have concentric tip, and no tip rollback observed from test results of part ii: tip transition deformation check from dhf tss 6.10.6.At this point, it can be concluded that unknown factors most probably contributed to the event.Field b3, date of event has been populated with the first day of february as an approximate, since only the bsc aware date has been provided, no event date is available.
Event or Problem Description
It was reported that during a procedure, a versacross sheath was selected for use.During the procedure it was difficult to cross the septum.No further details were reported.No patient complications were reported.The lot number provided could not be populated in the system.It was further reported that the physician believes it was tortuous anatomy with calcium build up on the septum.He believes the transition from the dilator to the sheath gave them issue.They ended up trying a new sheath and crossed just fine.He said this is a pretty common event when there is a lot of calcium build up on the septum.

• 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: 16726407
• Report Number: 2124215-2023-11330
• Device Sequence Number: 17713609
• Product Code: DYB
• UDI-Device Identifier: 00685447011729
• UDI-Public: 00685447011729
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/30/2023
• 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: 07/26/2025
• Device Model Number: VXSK0021
• Device Lot Number: VXFA141122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown