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

Lot Number	VXF030124B
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	05/21/2024
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 perforation and a pericardial effusion (pe) occurred.The procedure was cancelled.During the procedure, a versacross access solution kit was selected for use during a watchman left atrial appendage closure (laac) procedure.The patient has arrived, it was intubated, and a transesophageal echocardiography (tee) imaging was obtained.The first transseptal puncture was performed with no issues, however since the versacross rf wire was not visualized once in the left atrium (la), it was decided to go for a second transseptal puncture, when an effusion was checked and noticed a trace pericardial effusion (inferior and posterior) and a perforation confirmed.Thus, the second transseptal attempt was not performed.Then, protamine was given to the patient and the procedure was cancelled.The patient was monitored for 30 minutes and no change in the effusion was noted.Therefore, the patient was then admitted to the hospital for further monitoring, and it was expected to fully recover.No intervention was reported to be required.Product is not expected to return for analysis (disposed).Prior to the procedure, no pe was noted.The patient was not on warfarin at this time, although they were taking xarelto (anti-platelet).It was also mentioned that there were at least two attempts to track up and down to the septum.In the physician's opinion, the versacross rf wire and dilator did not malfunction during the procedure, however, the versacross rf wire may have perforated during transseptal causing the pe.No other issues were reported.

• Brand Name: VERSACROSS 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 DE COSTA RICA SRL; la lima business park; la lima, 03 ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19510463
• Report Number: 2124215-2024-35509
• Device Sequence Number: 17008354
• Product Code: DXF
• UDI-Device Identifier: 00685447011729
• UDI-Public: 00685447011729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/11/2024

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: 03/03/2026
• Device Lot Number: VXF030124B
• 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: 05/21/2024
• Initial Report FDA Received Date: 06/11/2024
• Date Device Manufactured: 01/03/2024
• 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: Female