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

Lot Number	VMFA310723
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	12/19/2023
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 trivial pericardial effusion and cardiac tamponade occurred.The procedure was cancelled.During a watchman procedure to treat left atrial appendage closure (laac), a versacross connect kit was selected for use.The patient had an aneurysmal septum, the physician crossed septum in an inferior, mid manner.The versacross dilator and the watchman sheath stuck tenting at septum and then jumped across the left atrium.The patient blood pressure decreases and anesthesia staff increased the blood pressure of the patient throughout the procedure.The left atrium looked compressed and a trivial baseline pericardial effusion was noted.The trivial pericardial effusion at baseline remained the same and no other effusion was noted.The patient was stable, but the physician did continue the procedure due to the atrium changing shape and patient's low blood pressure.Patient went to unit intubated.The procedure was aborted.Computed tomography (ct) will be performed and the patient remains under physician monitoring.It was further reported ct confirmed a small pericardial effusion or hematoma sourced from transseptal puncture to the left atrium wall (resolved, patient went home next day).In (b)(6) 2024 the patient underwent a successful left atrial appendage closure (laac) procedure.

• 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: 18848787
• Report Number: 2124215-2024-12403
• Device Sequence Number: 7439240
• Product Code: DXF
• UDI-Device Identifier: 00685447012573
• UDI-Public: 00685447012573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/06/2024

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 Expiration Date: 08/03/2025
• Device Lot Number: VMFA310723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White