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

Lot Number	0034057190
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on analysis completed on 26-sep-2024.It has been reported that a versacross access solution kit was selected for use a pulmonary vein isolation (pvi) procedure.Prior to the procedure, the user mentioned that the versacross rf wire was kinked after removing the device from the packaging and could not be used.A new kit was then opened, and the procedure was completed successfully.No patient complications were reported.Product will be returning for analysis.However, analysis revealed that the versacross rf wire has also an insulation damage.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory, the versacross rf wire was first visually inspected, and it failed, since the reported allegation of a kinked device was noted, and a non-reported insulation damage (slicing) was also revealed on the body of the rf wire.Next, the device passed the dimensional test since its electrode height, heat shrink gap, wide body outer diameter and proximal end outer diameter were within specifications.Therefore, the reported allegation of kinked rf wire was confirmed.However, due to the insulation damage noted to rf wire, this initial mdr report is being filed.

• 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 CORPORATION; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20409860
• Report Number: 2124215-2024-63107
• Device Sequence Number: 18122855
• Product Code: DXF
• UDI-Device Identifier: 00685447011729
• UDI-Public: 00685447011729
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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 Lot Number: 0034057190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown