MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Lot Number	0034521341
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/03/2024
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.
Event or Problem Description
A perforation, a pericardial effusion and a cardiac tamponade occurred.During an atrial fibrillation ablation, a versacross access solution was selected for use.First, transseptal puncture for the procedure was achieved using a versacross system (with no issues reported) and then a non-boston scientific mapping catheter was used to map the patient's left atrium.The ablation portion of the procedure was completed using a farawave pfa catheter.No complications or issues were noted during the procedure; however, after the catheters had been removed from the body and the sheath had been pulled back into the right atrium the patient's blood pressure dropped.A pericardial effusion was confirmed through transesophageal echocardiography (tee) to be surrounded right and left ventricles, and pericardiocentesis was performed.At this point, fluoroscopy revealed cardiac tamponade.The drained blood was found to be arterial blood, and the physician believes a perforation occurred in the left atrium.The patient stabilized and the procedure was then completed.It was expected the patient to fully recover.The device is not expected to be returned for analysis.There is no reason to believe that the versacross rf wire nor dilator malfunctioned during the procedure.Perforation had to have occurred at some point, likely toward the end of the case.Because blood drained from the pericardial sac was arterial, perforation could have been caused by any of the left atrial catheters or wires or transseptal puncture.The perforation was likely due to the physician pushing the bsc starter wire (rosen wire) far out the left atrial appendage during ablation when he meant to wire the left superior pulmonary vein (lspv).In the physician's opinion, the adverse event occurred either during transseptal or through the left atrial appendage, and the versacross dilator did not contribute to it.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY 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: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20287564
• Report Number: 2124215-2024-59353
• Device Sequence Number: 7171435
• Product Code: DXF
• UDI-Device Identifier: 00685447011736
• UDI-Public: 00685447011736
• 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
• 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): 09/23/2024

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 Lot Number: 0034521341
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/23/2024
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Race: White