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

Model Number	VXAK0007
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a thrombus was noted.During an atrial fibrillation (af) ablation with watchman implant, a versacross connect for faradrive was selected for use.The patient had pacemaker leads.The patient had been fully hepranized prior to transseptal crossing.Act reading was 354.The transseptal puncture (tsp) was successful and when advancing intracardiac echocardiography (ice) catheter over to the left atrium (la), a clot was noted to be in la hugging aorta.The physician tried to bring faradrive sheath closer to clot and aspirate but it would not move.At the time it was a non-mobile structure, and the physician was unsure of what this foreign object.The physician removed everything from la and called for transesophageal echocardiogram (tee) to get a closer look at the object and additional physicians to come for a second opinion.When performing tee, the structure moved over to the left atrial appendage (laa).At this point, the physicains determined it was likely a clot that the faradrive sheath may have grabbed off one of the pacemaker leading on right side and was brought over to la.The decision was made by the physicians to abort af ablation portion of procedure and continue with watchman procedure.The device is not expected to be returned for analysis (disposed).
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.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.
Event or Problem Description
It was reported that a thrombus was noted.During an atrial fibrillation (af) ablation with watchman implant, a versacross connect for faradrive was selected for use.The patient had pacemaker leads.The patient had been fully heparinized prior to transseptal crossing.Act reading was 354.The transseptal puncture (tsp) was successful and when advancing intracardiac echocardiography (ice) catheter over to the left atrium (la), a clot was noted to be in la hugging aorta.The physician tried to bring faradrive sheath closer to clot and aspirate but it would not move.At the time it was a non-mobile structure, and the physician was unsure of what this foreign object.The physician removed everything from la and called for transesophageal echocardiogram (tee) to get a closer look at the object and additional physicians to come for a second opinion.When performing tee, the structure moved over to the left atrial appendage (laa).At this point, the physicians determined it was likely a clot that the faradrive sheath may have grabbed off one of the pacemaker leading on right side and was brought over to la.The decision was made by the physicians to abort af ablation portion of procedure and continue with watchman procedure.The device is not expected to be returned for analysis (disposed).It was further confirmed that the versacross device was in the body when the problem began.There was no system malfunction reported.The physician does not think any of our products contributed to the complication.Patient was not hospitalized for extended time.The patient was later discharged.
Additional Manufacturer Narrative
Due to additional information received, this supplemental report is being submitted for the updated fields describe event or problem (b5), in section b - adverse event or product problem.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.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 CONNECT LAAC 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): 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 ; CA 55112 ; 6514400979
• MDR Report Key: 22543577
• Report Number: 2124215-2025-48053
• Device Sequence Number: 18261900
• Product Code: DXF
• UDI-Device Identifier: 00685447010524
• UDI-Public: (01)00685447010524
• 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,Followup
• Report Date (Section B): 08/11/2025

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: VXAK0007
• Device Catalogue Number: VXAK0007
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown