MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 06/07/2023

Event Type  Injury  

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 Description

A versacross connect kit was selected for a left atrial appendage (laa) closure procedure prior to the commencement of the procedure a baseline effusion was noted.Due to tortuosity, it was noted that there was a little trouble getting watchman assess system (was) and connect with versacross pigtail wire in the superior vena cava (svc), after the pigtail wire was removed from the superior vena cava and the guidewire was inserted the patient experienced supraventricular tachycardia.The transeptal puncture was completed, and the supraventricular tachycardia subsided.The closure device was implanted, and the procedure successfully concluded.Fifteen (15) minutes into recovery the patient became hypotensive and underwent a transthoracic echocardiogram which revealed cardiac tamponade.A pericardial tap was performed, and the pericardial drain was removed one day post index procedure.The patient fully recovered and was discharged two days post index procedure.

• Brand Name: VERSACROSS CONNECT LAAC ACCESS SOLUTION
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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 ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17545790
• MDR Text Key: 321133706
• Report Number: 2124215-2023-42761
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: WATCHMAN FLX DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Race: White