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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	09/24/2024
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, pericardial effusion and bradycardic occurred.During a farapulse pulmonary vein isolation (pvi) procedure, a versacross connect for faradrive kit was selected for use.The procedure was completed using the faradrive sheath, farawave ablation catheter and versacross connect.At some point during procedure, the patient was very bradycardic (- 30 bpm).But no effusion was noted on intracardiac echocardiography (ice) and pvi procedure went unremarkable.The versacross device is not expected to be returned for analysis.Then during cavotricuspid isthmus (cti) ablation procedure indicated for typical right atrial flutter, a non-boston scientific rf ablation catheter with the vizigo sheath to ablate the cti were used.During the last rf application, the physician felt a 'pop'.At that point, the patient became hemodynamically unstable.A pericardial effusion was noted on ice.A contrast injection was attempted to aid in visualization of the perforation occurred, but the findings were inconclusive.The patient was subsequently tapped more than three times to drain the pericardial space and was intubated and received blood product transfusion.The patient was consulted by cardiothoracic surgery and admitted to the intensive unit of care (icu).The patient became bradycardic after first pulse field ablation application in the left superior pulmonary vein (lspv).On (b)(6) 2024, it was notified that the patient ultimately required surgical intervention.It was discovered that there had been a steam-pop occurred during rf ablation of the cti at the right atrium-inferior vena cava (ivc) junction.In the physician opinion, this event was unrelated to pfa and the ablation of af in the left atrium.The patient is expected to recover.In the physician opinion, there were no versacross issues, malfunctions or contributions to the patient complication noted due to versacross devices.

• Brand Name: VERSACROSS CONNECT ACCESS SOLUTION FOR FARADRIVE
• 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): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20401236
• Report Number: 2124215-2024-62873
• Device Sequence Number: 3351301
• Product Code: DXF
• UDI-Device Identifier: 00685447019060
• UDI-Public: 00685447019060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/08/2024

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
• 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: 09/24/2024
• Initial Report FDA Received Date: 10/08/2024
• 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; Hospitalization; Life Threatening
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Race: White