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

Lot Number VMFD110923

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/22/2024

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 has been reported that a versacross connect access solution was selected for use for a watchman procedure.A thrombus was noted.During the procedure, the physician mentioned that 50 un/kg of heparin was given to the patient prior to attempting transseptal.As they were advancing the versacross device with the watchman sheath through the inferior vena cava (ivc), and into the right atrium, they visualized a thrombus on the tip of the versacross dilator and mechanical guidewire using transesophageal echocardiography (tee).They attempted to aspirate the thrombus by using the watchman sheath introducer but were unsuccessful.Next, it was decided to remove the entire system under negative pressure, after giving an additional 50 un/kg of heparin prior to removal.When the device was removed, no thrombus was noted on the watchman or on the versacross connect devices.The procedure was then completed successfully.Product is not expected to return for analysis (disposed).In the physician's opinion, the versacross devices did not contribute to the clot, instead it is believed it was due to the late administration of heparin.The thrombus was noted prior to any transseptal attempts being made.At the second dose of heparin act was taken (383 sec).Although, act after heparin completion was 283sec.They then gave an extra 3000 units and the final act was 334sec.Total elapsed time between initial and last act was roughly 10 minutes.The irrigation flow rate was 50 cc-hr and was not interrupted during the procedure.No thrombus was noted prior to procedure and a pre-procedure computed tomography (ct) was also performed.The procedure was performed on an interrupted anticoagulation regimen.The patient was on aspiring prior to the procedure, heparin bolus during the procedure, and asa-plavix post-procedure.No fibrin or coagulant was seen on the tip of the devices.

• 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: 18938354
• MDR Text Key: 338068712
• Report Number: 2124215-2024-15947
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/19/2024

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
• Device Lot Number: VMFD110923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other