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

Lot Number	VMFA080823
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pericardial effusion (pe), perforation, hematoma and cardiac tamponade occurred.During watchman left atrial appendage (laa) closure procedure, a versacross connect was selected for use.The transseptal puncture (tsp) was performed and the watchman closure device was implanted.A pericardial effusion was noted by the echo physician.A pericardiocentesis was performed however the bleeding did not stop.The patient was transferred to surgery where a small perforation was identified in the descending aorta and was repaired.The physician suspected that the perforation may have occurred during tsp.The patient was admitted to the surgical intensive care unit.The device is not expected to be returned for analysis.It was further confirmed the pe was first noticed by transesophageal echocardiogram (tee) physician during the device deployment.There was no difficulty noted with patient anatomy, or required multiple attempts to track up / drop down into position on septum.There was no imaging/visualization issues.Per physician there was no issues noted with the tsp or any of the versacross devices.
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 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: 18810646
• Report Number: 2124215-2024-11446
• Device Sequence Number: 8239869
• Product Code: DXF
• UDI-Device Identifier: 00685447012566
• UDI-Public: 00685447012566
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/29/2024

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: VMFA080823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/29/2024
• 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; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White