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

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

Patient Problems Hematoma (1884); Perforation of Vessels (2135); Pericardial Effusion (3271)

Event Date 10/20/2023

Event Type  Injury  

Event Description

It was reported a perforation, hematoma and pericardial effusion occurred.The procedure was cancelled.It was during a watchman left atrial appendage closure (laac) procedure, a versacross connect kit was selected for use.Once the connect kit was placed in watchman sheath in the superior vena cava (svc), it was tough patient anatomy causing with difficulty imaging (transesophageal echocardiogram tee).The physician could not cross the septum and the aorta was perforated.It was noted hematoma and effusion was caused.Patient was given to reverse heparin and hematoma was stabilized.Patient was then sent to the icu to be closely monitored and expected to be fully recovered.The device is not expected to be returned for analysis.Only a hematoma noted around the aorta in 45 degree tee.The patient had rotated heart.There was difficulty getting on to the septum to get across and to visualize tenting prior to rf application.Transseptal puncture was never crossed and could not find the wire after added current to it.The physician never truly crossed the septum.Wire went into the aorta.Everything was pulled back and versacross connect/ sheath were never pushed from the right atrium.There were multiple attempts required to track up / drop down into position on septum.Perforation might have been to anterior.Radio frequency was applied two times one second constant.After the wire could not be found in the left atrium we swept for effusion finding the hematoma on the aorta.Patient was admitted to icu for monitoring and discharged home one day after.

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
• Type of Device: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 18106328
• MDR Text Key: 327785838
• Report Number: 2124215-2023-62933
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220414
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White