MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Lot Number	0034502456
Medical Device Problem Codes	Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
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 has been reported that a versacross access solution kit was selected for use for a pulse field ablation procedure.During the procedure, the user mentioned the tip of the dilator was noted to be defective, looking to be flattened causing difficulty during insertion/advance it.The device was replaced, and the procedure was completed successfully.No patient complications were reported.Product is available for return.The damage was seen after inserting the dilator into the sheath.No other issues were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the versacross dilator was visually inspected and did flush properly before and after decontamination.Also, it was noted that its tip revealed damage, making it appear slightly ovalized while tested via vxh, indicating an attempt to track a kinked wire which could have led to difficulty during insertion.Later, during a device-to-device interaction testing, a sample wire was tracked through the versacross dilator which confirmed that there were no issues with respect to wire insertion.No issues with insertion into sheath.The reported allegation was confirmed.
Event or Problem Description
It has been reported that a versacross access solution kit was selected for use for a pulse field ablation procedure.During the procedure, the user mentioned the tip of the dilator was noted to be defective, looking to be flattened causing difficulty during insertion/advance it.The device was replaced, and the procedure was completed successfully.No patient complications were reported.Product is available for return.The damage was seen after inserting the dilator into the sheath.No other issues were reported.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: 20410028
• Report Number: 2124215-2024-63070
• Device Sequence Number: 9104863
• Product Code: DYB
• UDI-Device Identifier: 00685447011736
• UDI-Public: 00685447011736
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183655
• 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): 01/15/2025

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: 0034502456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown