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

Lot Number	0033503768
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cardiac perforation, pericardial effusion, cardiac tamponade and blood loss occurred.The procedure was cancelled.It was reported that during a cardiac ablation procedure, a versacross connect kit for faradrive (j-wire version) was selected for use.The transseptal puncture (tsp) was completed with no issues.However, it may had been possible that the radio frequency (rf) was delivered inadvertently after the transseptal wire crossed into the left atrium.Then, a non-boston scientific mapping catheter (pentaray) was inserted, and a left atrial geometry collected with no issues.The farawave with a non-boston scientific guidewire (merit) were inserted.The team utilized a mapping system (carto) and visualization tools to be able to approximate the guide wire location fluoro-less.The left pulmonary veins were ablated without any issue, however afterwards anesthetist detected a drop in blood pressure.The operating physician did a view of the heart with intracardiac echo (ice) and immediately noticed a pericardial effusion.Immediate interventions were performed to relieve blood drainage into the pericardial space, including pericardiocentesis where several hundred cc of blood was collected.Once the effusion was greatly reduced, the patient was transferred to cardiac surgery and a sternotomy was performed.There were two small holes detected in the left atrial appendage (laa).It is unknown whether this occurred as a result of the transseptal puncture, multi-spline mapping catheter manipulation, or farawave catheter/wire manipulation.The procedure was not able to be completed due to the patient complications.The patient was held for observation and expected to recover.The device is not expected to be returned for analysis (disposed).It was further confirmed that there was a cardiac tamponade also noted.The perforation was noticed after left-sided veins ablated.No versacross device were inside patient body when pe was noted.No malfunctions were noted with the versacross devices.In the physician's opinion, it is unlikely that the versacross dilator and versacross rf wire contributed to the complication.The transseptal puncture was felt ideal by the physician, and a second tap of rf was not noticed.
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.

• 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): BOSTON SCIENTIFIC CORPORATION; 2775 matheson blvd east; mississauga, on L4W 4 P7; CA L4W 4P7
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19164558
• Report Number: 2124215-2024-24543
• Device Sequence Number: 12595244
• Product Code: DXF
• UDI-Device Identifier: 00685447019060
• UDI-Public: 00685447019060
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/23/2024

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: 0033503768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male
• Patient Race: White