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 Thrombosis/Thrombus (4440)

Event Date 02/14/2024

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 a reported a thrombus was noted and the procedure was cancelled.During a watchman procedure to treat atrial fibrillation (a fib) and high bleed risk, a versacross connect kit was selected for use.The venous access was gained and 14,000 unit of unfractionated heparin (ufh) was administered.The watchman sheath and versacross dilator were placed into the superior vena cava (svc) for the transseptal puncture (tsp).While coming down the svc, a thrombus was discovered, and it appeared to be attached to the septum.Hence, the devices were removed and the procedure was cancelled.No medical intervention was required and the patient was expected to be fully recovered, and it was discharged on (b)(6) 2024.The device is not expected to be returned for analysis (discarded).The thrombus was not seen in the echogenic density before initiate the tsp on any pre-imaging.After further discussion, since the structure was very posterior, it was possible that the imager missed it being pre-existing on the pre-transesophageal echocardiogram (tee) images.The physicians were not convinced this was new / acute thrombus.It was also mentioned that the rf wire was inserted in the versacross dilator when coming down to svc, however it was not exposed to the anatomy.The patient was maintained on anticoagulation.In the physician opinion, the versacross devices did not contribute to this event.

• 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: 18897706
• MDR Text Key: 337592042
• Report Number: 2124215-2024-14707
• 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: 03/13/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/13/2024
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male