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

Lot Number	0033394166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/20/2024
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 occurred, leading to a pericardial effusion (pe) and cardiac tamponade, procedure cancelled.During a watchman procedure, a versacross connect access solution kit was selected for use.The transseptal access was obtained at a mid/inferior position with no issues reported, then intracardiac echocardiography (ice) was advanced across the left atrium (la), also as the watchman sheath and a non-boston scientific pigtail catheter.A picture was then taken, and shortly after a decrease in pressure was noted.At this point, a large pe was noticed primarily on the right side of the heart.A pericardial tap was performed, along with removing 1000ml and giving back 900ml.Therefore, the procedure was cancelled, patient was taken to intensive care unit (icu) for further monitoring, and it was later discharged.The device is not expected to be returned for analysis (disposed).Prior to the procedure, there no pe noted on echo.The patient was not on warfarin or any antiplatelet drugs at this time.In the physician's opinion, it was not possible to determine where the perforation occurred or the exact cause of the pericardial effusion.The transseptal site was said to be in a safe location, and no malfunction was reported along with versacross devices, although it is believed it may have been due to either the ice catheter or catheter manipulation.

• 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): 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: 19711416
• Report Number: 2124215-2024-42563
• Device Sequence Number: 18287296
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/10/2024

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: 0033394166
• 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: 06/20/2024
• Initial Report FDA Received Date: 07/10/2024
• Date Device Manufactured: 02/01/2024
• 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; Life Threatening; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male