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

Model Number	VSTK0016
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
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 steerable access solution was selected for pulmonary vein isolation procedure.During the procedure, when versacross rf wire was introduced into the patient body from the transseptal sheath, and the outer coating of the transseptal wire came out from right side of the marker band.Thus, the versacross rf wire was replaced and new transseptal wire was used form the different versacross kit and the procedure was completed successfully.No patient complications were reported.The device is expected to be return for analysis.The device was intact and was removed without any further compromise.Its insulation stripped off at its proximal end.The issue was noted when the physician was initially finding the marker band for reference to move to the groin access site, a small tab attached from the proximal end was noted.The distal tip was not to the heart when this was discovered and the de-insulated part never went into any other device, only came out of the hoop.The rf wire was inserted into a hemostatic valve on a short sheath.
Event or Problem Description
It was reported that versacross steerable access solution was selected for pulmonary vein isolation procedure.During the procedure, when versacross rf wire was introduced into the patient body from the transseptal sheath, and the outer coating of the transseptal wire came out from right side of the marker band.Thus, the versacross rf wire was replaced and new transseptal wire was used form the different versacross kit and the procedure was completed successfully.No patient complications were reported.The device is expected to be return for analysis.The device was intact and was removed without any further compromise.Its insulation stripped off at its proximal end.The issue was noted when the physician was initially finding the marker band for reference to move to the groin access site, a small tab attached from the proximal end was noted.The distal tip was not to the heart when this was discovered and the de-insulated part never went into any other device, only came out of the hoop.The rf wire was inserted into a hemostatic valve on a short sheath.The product was received for analysis.
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 was found to have coating damage near the second marker of the rf wire.Also, the rf wire passed all other device specifications.The reported allegation of coating issue was confirmed through the product investigation.The cause code of 'failure to follow instructions' was selected, since the only way to create this failure mode is through insertion/retraction in a metal introducer.The instructions for use of the device 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'.We are unable to provide the complete unique identifier (udi) at the time of the submission of this report, as it was not yet available.If additional details become available, a supplemental report will be submitted.

• Brand Name: VERSACROSS STEERABLE ACCESS SOLUTION
• 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: 21256488
• Report Number: 2124215-2025-04162
• Device Sequence Number: 21095811
• Product Code: DXF
• UDI-Device Identifier: 00685447007135
• UDI-Public: 00685447007135
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/20/2025

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: VSTK0016
• Device Catalogue Number: VSTK0016
• Device Lot Number: 0035138138
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male