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

Model Number	VXAK0047
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Visual Disturbances (2140); Thrombosis/Thrombus (4440)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.Detailed product information was not provided to bsc.Good faith efforts to obtain the information are in progress.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information at this time.A supplemental report will be filed if the information is received.Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained yet.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that patient experienced stroke.During a farapulse atrial fibrillation procedure, a versacross connect for faradrive was selected for use.Access was performed for insertion of an intracardiac echocardiography (ice) catheter and a faradrive sheath.First the physician decided to ablate the cti line with farapulse, and then the physician used the grid mapping catheter on the cti line.Next, the physician attempted to map the cti line with the grid catheter.It was at this time that this afs clinical noticed there was thrombus on the grid mapping catheter on ice.The physician aspirated the sheath and re-sheathed the grid and removed it from the body.The grid was then pulled out, and the sheath was flushed following aspiration with a 20cc syringe.Then, the versacross faradrive connect was introduced, and transeptal puncture was successfully performed.The physician performed the ablations on each vein without incident.The exact number of applications with the farapulse are in the report.The physician believes that there may have been an embolic event following transeptal from the clot that was present after cti line application and mapping with the grid.The physician understood that cti ablation with the farawave is off label use.There were no surgical interventions took place.The device is not expected to be returned for analysis (disposed).

• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 22471909
• Report Number: 2124215-2025-46082
• Device Sequence Number: 12726055
• Product Code: DXF
• UDI-Device Identifier: 00685447019077
• UDI-Public: (01)00685447019077
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: VXAK0047
• Device Catalogue Number: VXAK0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 2 MO
• Patient Sex: Female
• Patient Race: White