MAUDE Adverse Event Report: BAYLIS MEDICALE CIE INC VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE; CATHETER, SEPTOSTOMY

Model Number	VXAK0045
Medical Device Problem Codes	Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a versacross connect access solution kit for faradrive was selected for use for atrial fibrillation (a fib) ablation procedure.During the procedure, it was mentioned that when the physician was accidentally inserting the versacross rf wire into a non-boston scientific introducer needle (cook), the rf wire became stripped.A new versacross kit was then opened to replace the wire, and the procedure was completed successfully without the use of the introducer needle.No patient complications were reported.Product is expected to be returned for analysis.The physician was unaware that the versacross rf wire cannot be inserted into a cook introducer needle.
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.
Additional Manufacturer Narrative
The device has been received for analysis.Upon receipt at our post market quality assurance laboratory, the versacross rf wire was visually inspected and found to have its insulation damaged.Next, during dimensional test, the returned device met its design specification for the distal and proximal outer diameters.A labeling review was conducted, and it was determined there was evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use, which warns the user to 'do not use excessive force to advance or withdraw the versacross rf wire or ancillary sheath and/or dilator assembly.Excessive force may lead to bending or kinking of the device limiting advancement and retraction of sheath and/or dilator device'.Furthermore, the ifu provides the warning: 'do not attempt to insert or retract the versacross rf wire through a metal cannula or a percutaneous needle, which may damage the device and may cause patient injury.'.The reported allegation has been confirmed for the insulation damage to the rf wire.Also, the field unique identifier (udi) (d4) and implant date (d6a) in section suspect medical device were updated.
Event or Problem Description
It has been reported that a versacross connect access solution kit for faradrive was selected for use for atrial fibrillation (a fib) ablation procedure.During the procedure, it was mentioned that when the physician was accidentally inserting the versacross rf wire into a non-boston scientific introducer needle (cook), the rf wire became stripped.A new versacross kit was then opened to replace the wire, and the procedure was completed successfully without the use of the introducer needle.No patient complications were reported.Product is expected to be returned for analysis.The physician was unaware that the versacross rf wire cannot be inserted into a cook introducer needle.The device has returned for analysis.

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICALE CIE 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 21138183
• Report Number: 2124215-2025-00996
• Device Sequence Number: 6982634
• Product Code: DXF
• UDI-Device Identifier: 00685447019060
• UDI-Public: (01)00685447019060(17)270612(10)34491404
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/03/2025

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 Model Number: VXAK0045
• Device Catalogue Number: VXAK0045
• Device Lot Number: 0034491404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 03/16/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown