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

Lot Number	VXFD230323
Medical Device Problem Codes	Defective Device (2588); Device-Device Incompatibility (2919); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has 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 pulmonary vein isolation procedure to treat atrial fibrillation, a versacross access solution kit was selected for use.The versacross rf wire was inserted into a non-boston introducer sheath, and advanced into the heart (a non-boston scientific tip straightener was used to insert versacross rf wire through introducer sheath and into the body).Thus, after removing the non-boston introducer sheath, the versacross sheath/dilator were backloaded in the back of the versacross rf wire (back of the wire into the tip of the dilator).At a certain point, the coating of the wire came off and bunched up at a point where the sheath and dilator could no longer be advanced over that section of the wire.The insulation was intact but peeled back at proximal end.Hence to resolve the issue, a new kit was opened and the procedure was completed successfully.No patient complications reported.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has been received for analysis.Investigation approved.The device was returned for analysis.Analysis of the device found insulation bunching, unable to fully insert.From the information provided in the complaint summary and the returned product investigation, the potential root cause cannot be determined with full certainty.It is highly probably that the following root cause occurred: - excessive force used when backloading wire - physician/scrub tech technique.The device met its design specifications for wire body od, proximal end od, electrode height, and electrode/heat shrink gap.Based on the information provided in the complaint summary as well as based on the results of the testing/inspections performed, the reported allegations can be confirmed.Images provided of the returned complaint confirm the insulation damage.However, it cannot be concluded with certainty what the root cause of this event was.It is possible that the wire was backloaded with excessive force which could cause damage to the rf wire.Therefore, unintended use error caused or contributed to event cause code was selected.
Event or Problem Description
It was reported that during a pulmonary vein isolation procedure to treat atrial fibrillation, a versacross access solution kit was selected for use.While the sheath and dilator were being prepared, the versacross rf wire backloaded into the dilator and sheath (back of the wire into the tip of the dilator).At a certain point, the coating of the wire came off and bunched up at a point where the sheath and dilator could no longer be advanced over that section of the wire (photos attached).Hence to resolve the issue, a new kit was opened and the procedure was completed successfully.No patient complications reported.The device is expected to be returned for analysis.Product returned, investigation approved.The device was returned for analysis.Analysis of the device found insulation bunching, unable to fully insert.From the information provided in the complaint summary and the returned product investigation, the potential root cause cannot be determined with full certainty.It is highly probably that the following root cause occurred: - excessive force used when backloading wire - physician/scrub tech technique the device met its design specifications for wire body od, proximal end od, electrode height, and electrode/heat shrink gap.Based on the information provided in the complaint summary as well as based on the results of the testing/inspections performed, the reported allegations can be confirmed.Images provided of the returned complaint confirm the insulation damage.However, it cannot be concluded with certainty what the root cause of this event was.It is possible that the wire was backloaded with excessive force which could cause damage to the rf wire.Based on the testing results as well as on the information provided in the complaint summary, it was concluded that the wire was backloaded into the sheath and dilator with excessive force.Therefore, unintended use error caused or contributed to event cause code was selected.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: 17453578
• Report Number: 2124215-2023-40455
• Device Sequence Number: 17996029
• Product Code: DXF
• UDI-Device Identifier: 00685447011828
• UDI-Public: 00685447011828
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 09/28/2023

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: 01/26/2026
• Device Lot Number: VXFD230323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown