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

Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/22/2024
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 and pericardial effusion (pe) occurred.During a watchman left atrial appendage occlusion procedure, a versacross connect access solution kit was selected for use.The venous access was obtained in the right femoral vein and a non-boston scientific 6 fr.Sheath was inserted.The versacross rf wire was inserted and advanced to the superior vena cava (svc), and during advancement, the versacross rf wire initially tried to track into the right hepatic vein but was successfully advanced to the svc.Then, non-boston scientific 6 fr.Sheath was exchanged, the tip of the verscacross rf wire was retracted into the versacross dilator and a drop down to the fossa ovalis was performed.Once the desired puncture location was obtained, the transseptal crossing was completed.The versacross rf wire was then advanced blindly into the left atrium.Once the rf coil of the wire was located, it was found to be in the wall of the left atrial appendage, with the pigtail tip partially distorted in shape.The sheath and dilator were then advanced across the septum, followed by the dilator being removed.A non-boston scientific 6 fr pigtail catheter was then inserted over the versacross rf wire and advanced into the left atrium appendage (laa).A left atrial pressure was measured and recorded and an appendogram was performed in the rao/cau view, when the physician noted a pericardial effusion on transesophageal echocardiography (tee).Also, minimal drop in blood pressure was note, but did not required intervention.A 31 mm watchman flx device was opened and inserted/deployed and released as it passed criteria to help slow blood loss into the pericardial space.Thus, the patient's chest was quickly prepped and using a pericardiocentesis tray, the pericardial space was accessed and approximately 600 cc of bright red fluid surrounding the heart was aspirated.Heparin was also reversed using protamine sulfate and the laa appendage was seen to begin clotting behind the watchman device.The patient was then transferred to the recovery unit for further monitoring, but they fully recovered and was discharged.The device is not expected to be returned for analysis (disposed).Prior to the procedure, no pe was noted.The patient was not on warfarin or any antiplatelet drugs during the procedure.There was no difficulty visualizing the versacross rf wire on tee or fluoroscopy prior to or immediately following the puncture.In the physician's opinion, the versacross rf wire was advanced into the left atrial appendage, puncturing the appendage wall leading to a pericardial 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 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: 19523370
• Report Number: 2124215-2024-35957
• Device Sequence Number: 17649908
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/12/2024

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: 05/22/2024
• Initial Report FDA Received Date: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White