MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Lot Number	0034023539
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a pulse field ablation procedure to treat atrial fibrillation (a fib), a versacross connect for faradrive kit was selected for use.The versacross dilator was prepped to be inserted in faradrive sheath.When the dilator was in the sheath and was about to have the wire loaded through the dilator, the physician noticed that the tip of the dilator was defective.The defect was described as 'a little melted or that it has extra plastic to one side of the tip'.Hence to resolve the issue, both the sheath and dilator were replaced, and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.However, analysis revealed that the dilator tip was defective and deformed, along with a slitting of dilator tip, an angled cut has created a 'flap' of material on outside surface and the tip has not ovalized.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory, the versacross dilator was first visually inspected, and it failed, since a slitting of dilator tip was noted, an angled cut has created a 'flap' of material on outside surface and the tip has not ovalized.The dilator has passed the device-to-device interaction.From benchtop analysis, excessive force or inattention by the user during preparation could have caused the observed failure.The cause of the damage cannot be confirmed because the available information is not enough to determine what specifically caused the failure.The returned product confirms tip damage, but the cause is not determined.There is no evidence that the device failed to meet applicable product specifications prior to shipment.

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20180475
• Report Number: 2124215-2024-56382
• Device Sequence Number: 8364786
• Product Code: DRE
• UDI-Device Identifier: 00685447019060
• UDI-Public: 00685447019060
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233647
• 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): 09/10/2024

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: 0034023539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown