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

Lot Number	VMFB080823
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pericardial Effusion (3271)
Date of Event	01/08/2024
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
It was reported that a pericardial effusion and blood loss occurred.During a left atrial appendage occlusion (laao) procedure to treat atrial fibrillation (a fib), a versacross connect kit was selected for use.Prior to the procedure, a 2mm baseline pericardial effusion was identified.The patient was administered heparin prior to the transseptal puncture (tsp), the activated clotting time (act) was 404.Difficulty was experienced performing the tsp due to patient anatomy and enlarged atria.Device was pulled out several times to adjust the curve shape and once tenting was confirmed, tsp was completed.There was difficulty visualizing the radio frequency (rf) wire in the laa following the tsp.The baseline effusion increased in size to 3mm around right atrium and a pericardiocentesis was performed.Approximately on liter of blood was removed and two units of blood were transfused.The watchman device was implanted successfully.Angiography and transthoracic echocardiogram revealed the pericardial effusion was stable.The patient remained stable and the procedure was successfully completed.The patient was admitted overnight for monitoring and is expected to fully recover.The device is not expected to be returned for analysis.It was further confirmed that there were multiple attempts required to track up / drop down into position on septum.Both versacross dilator and watchman sheath were being pulled out to re-shape curve to make one tsp system.No issues noted with the dilator.After the complication, the physician stated that the rf wire was not acting like a normal curly rf wire.It was the rf wire with difficult visualization.The rf wire was tenting around 3-5mm for the successful cross.They attempted using rf at least once prior to crossing accurately, however it never got a proper tent on the septum until the last attempt that successfully went through.There was a potential reason to believe the rf wire did malfunction causing the effusion.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Common Device Name: CATHETER, SEPTOSTOMY
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal, qc 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18610395
• Report Number: 2124215-2024-04284
• Device Sequence Number: 2368733
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/30/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2025
• Device Lot Number: VMFB080823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Race: Black Or African American