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

Lot Number	VXF100823F
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
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 versacross access solution was selected for use during an atrial fibrillation (a fib) ablation.During the procedure, the sheath/dilator became bent/kinked/deformed, and it was noticed that the insulation material on the versacross rf wire at the proximal end was pulling away from the device and unraveling.No patient complications were reported.The procedure was completed successfully.The issue was noted upon opening the package.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The returned rf wire was analyzed.This is supplemental mdr to report investigation results (mdr aware date 30jan2024).Analysis of the device found that the insulation was damaged on the proximal end, and also it was kinked towards the center of the wire and the electrode was charred.The device passed inspection of wire body and proximal end other diameters.Also, the device passed electrode height inspection, and electrode/heat shrink gap inspections.The reported allegation was confirmed.
Event or Problem Description
It was reported that versacross access solution was selected for use during an atrial fibrillation (a fib) ablation.During the procedure, the sheath/dilator became bent/kinked/deformed, and it was noticed that the insulation material on the versacross rf wire at the proximal end was pulling away from the device and unraveling.No patient complications were reported.The procedure was completed successfully.The issue was noted upon opening the package.The device is expected to be returned for analysis.

• 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: 18352920
• Report Number: 2124215-2023-69689
• Device Sequence Number: 20530070
• Product Code: DXF
• UDI-Device Identifier: 00685447011835
• UDI-Public: 00685447011835
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/20/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/20/2024
• 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 Age: 65 YR
• Patient Sex: Female