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 Problem Stroke/CVA (1770)

Event Date 09/15/2023

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

It was reported that a versacross connect was used during a watchman procedure.It was mentioned that the patient had a neurological event post discharge from procedure.Patient returned to the hospital for intervention and it was discharged, and it was fully recovered.No clot was noticed during the procedure.There is no reason to believe that the versacross connect devices had any malfunction during procedure.The activated clotting time (act) was 250+.The irrigation was never interrupted or stopped during the procedure.The imaging performed to rule out thrombus pre procedure was transesophageal echocardiogram (tee).No pre procedure computerized tomography was performed.The procedure was performed on uninterrupted anticoagulation regimen.No fibrin or coagulant was seen on the tip of the devices at the procedure.No air was seen inside of the patient on imaging.All of the stroke symptoms were resolve within 24 hours.The patient was under general anesthesia during the procedure.After recovery, there were no neurological symptoms or issues present.The procedure was completed successfully.In the physician's opinion, the device or procedure contribute to the patient complication, but unsure how.The patient was admitted to hospital beyond standard of care.The device is not expected to be returned for analysis.

• 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 L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17980700
• MDR Text Key: 326242038
• Report Number: 2124215-2023-56810
• 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: 10/20/2023

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: 09/22/2023
• Initial Date FDA 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; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male