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

Lot Number	VXF100823F
Medical Device Problem Codes	Difficult to Insert (1316); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a versacross access solution was selected for use.Once tried to load the versacross rf wire, it had a roughed up coating (damage) and it would not advance into versacross sheath.Thus, a new device was opened.No patient complications were reported.The procedure was completed successfully.The device is expected to be returned for analysis.It was further noted that the issue happened once tried to load the wire.The versacross rf wire would not enter the sheath.The issue was noted with the rf wire and versacross sheath.It was difficulty noted during backloading the wire.The patient did not have any leads or mechanical hardware.The damage was noted on the wire before or after the difficulty reported.
Additional Manufacturer Narrative
The device has been received for analysis.The investigation of it found an insulation damage noted at the proximal end/connector area of the wire.The device passed the testing for inspection of wire body outer diameter (od) and proximal end od inspection.Also, it passed electrode height inspection, and electrode / heat shrink gap inspection.The reported allegation was confirmed.Thus, an initial mdr will be submitted (the aware date is 01mar2024).

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA SRL; la lima business park; la lima, 03 ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18961558
• Report Number: 2124215-2024-12894
• Device Sequence Number: 8051941
• Product Code: DXF
• UDI-Device Identifier: 00685447011835
• UDI-Public: 00685447011835
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

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: 01/19/2025
• Device Lot Number: VXF100823F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown