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

Model Number	VXSK0124
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
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 access solution selected for atrial flutter (af) ablation procedure.During the procedure, once transseptal access was being attempted in the left atrium, physician removed the versacross sheath and dilator leaving the versacross rf wire in place in the left superior pulmonary vein (lspv).When trying to backload the wire into the faradrive sheath and dilator for a sheath exchange into the left atrium (la), it was noted that the coating on the rf wire was preventing backloading of the wire into the sheath and dilator.Multiple attempts were made to backload the wire, but the coating seemed to peel back and create more of a hurdle to backloading the wire in.In an attempt to save the tsp puncture, the physician attempted to backload the versacross sheath back onto the rf wire instead.Unfortunately, they could no longer backload the rf wire into the versacross sheath either.Transseptal access was lost.Hence, the device was replaced and then able to get transseptal access again and was then able to easily backload the faradrive onto the new rf wire from the new versacross sheath and rf wire kit.The procedure was completed successfully.No patient complication was reported.The device is expected to return for analysis.
Additional Manufacturer Narrative
The device was received for analysis.Upon receipt at our post market quality assurance laboratory, the device was visually inspected and flaring was observed at proximal transition.Additionally, the device passed the dimensional test, as the wire outside diameter was within specification near and away from flaring.The reported allegation of insulation damage is confirmed based on testing the returned product.Correction to the initial mdr in block(s) init rptr also sent rep to fda (e4), in section e initial reporter.
Event or Problem Description
It was reported that versacross access solution selected for atrial flutter (af) ablation procedure.During the procedure, once transseptal access was being attempted in the left atrium, physician removed the versacross sheath and dilator leaving the versacross rf wire in place in the left superior pulmonary vein (lspv).When trying to backload the wire into the faradrive sheath and dilator for a sheath exchange into the left atrium (la), it was noted that the coating on the rf wire was preventing backloading of the wire into the sheath and dilator.Multiple attempts were made to backload the wire, but the coating seemed to peel back and create more of a hurdle to backloading the wire in.In an attempt to save the tsp puncture, the physician attempted to backload the versacross sheath back onto the rf wire instead.Unfortunately, they could no longer backload the rf wire into the versacross sheath either.Transseptal access was lost.Hence, the device was replaced and then able to get transseptal access again and was then able to easily backload the faradrive onto the new rf wire from the new versacross sheath and rf wire kit.The procedure was completed successfully.No patient complication was reported.The device is expected to return for analysis.

• Brand Name: VERSACROSS 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; zona franca la lima; cartgo, 03 30106 ; CS 30106
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22777186
• Report Number: 2124215-2025-55860
• Device Sequence Number: 9450016
• Product Code: DXF
• UDI-Device Identifier: 00685447019848
• UDI-Public: (01)00685447019848(17)280402(10)36400771
• 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): 10/28/2025

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: VXSK0124
• Device Catalogue Number: VXSK0124
• Device Lot Number: 0036400771
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown