MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS CONNECT LAAC ACCESS SOLUTION; CATHETER, SEPTOSTOMY

Lot Number VMFE131023

Device Problems Display or Visual Feedback Problem (1184); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/27/2024

Event Type  Injury  

Event Description

It has been reported that a versacross connect access solution was selected for use.A perforation, a pericardial effusion (pe) and cardiac tamponade occurred, and the procedure was cancelled.During watchman procedure, right femoral access was achieved.The transesophageal echocardiography (tee) showed a trace pe and no clotting in the appendage.Baseline measurements were performed, and heparin was given.The watchman sheath and the versacross dilator were advanced over the versacross rf wire into the superior vena cava (svc).Using tee, a safe inferior and mid transseptal crossing was successfully achieved (no issues noted).The system was then advanced into the left atrium.When the dilator was being removed from the sheath, the rf wire accidentally also got pulled back into the sheath.When the physician was attempting to advance the rf wire back through, they experienced resistance.At this point, tee was unable to visualize the device, and so fluoroscopy was used.Suddenly, the patient's blood pressure began dropping to 50/38 and a pe was noted behind the right and left ventricle.Protamine was given and a pericardiocentesis was performed, removing roughly 750ccs of blood from the body.The patient was then stabilized and a cardiac care unit (ccu) bed was ordered.The patient was successfully discharged from the facility on (b)(6) 2024.The device is not expected to be returned for analysis.In the physician's opinion, the versacross device contributed to the complications.After transseptal, the physician accidentally removed the versacross rf wire with the dilator, upon reinsertion of the rf wire, resistance was felt.The pe grew significantly throughout the procedure but returned to baseline at the end.Patient was not on warfarin or antiplatelet drugs at the time of procedure.There is no reason to believe that the versacross dilator malfunctioned during the procedure.They also confirmed that a full dose of heparin was given prior to transseptal and act was therapeutic during the procedure.

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: CATHETER, SEPTOSTOMY
• 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: 18951281
• MDR Text Key: 338259606
• Report Number: 2124215-2024-16588
• Device Sequence Number: 1
• Product Code: DXF
• UDI-Device Identifier: 00685447012597
• UDI-Public: 00685447012597
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150709
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: VMFE131023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White