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 Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 11/02/2023

Event Type  Injury  

Event Description

It was reported that a versacross connect was selected for use during a watchman procedure.The right groin femoral access was successful.The transseptal - interatrial septum was achieved using the verascross connect.The versacross rf wire was placed in the left upper pulmonary vein (lupv).A non-boston scientific pigtail was advanced over the versacross rf wire, which was then removed, and a contrast injection did not illuminate the appendage.Instead, it looked like it was going through the appendage.The patient was checked for an effusion and a large pericardial effusion (pe) was noted on the right ventricle (rv).Thus, a 100 mg of protamine was given, and a pericardiocentesis was done with 1400 cc of blood removed.The blood then started to clot, and a large clot formed causing a tamponade.Cardiopulmonary resuscitation (cpr) was started and a return of spontaneous circulation (rosc) was achieved.Cardiothoracic (ct) surgery was called and noted a clot in the pericardial space which they decided to surgically remove.The patient was sent to the operation room (or).An additional surgery was performed to fix the cardiac tamponade, that occurred as a result of protamine being given after the effusion was discovered.Blood loss occurred, and a blood transfusion was done.The procedure was cancelled, and the patient was admitted to the intensive care unit for four days.However, the patient then coded and passed away.No issues with the versacross connect were reported.It appeared like a very straight forward case.It was tried to go transseptal once, it was buzzed at the fat part of the septum and did not cross, then it was positioned to the inferior portion of the septum and crossed without difficulty.Perforation could not be estimated when happened.In the physician's opinion, the device contributed to the adverse event.The effusion likely occurred during transseptal puncture which was required for this procedure.No pe was noted prior to the procedure.The device is not expected to be returned for analysis.The was entry into the laa (left atrium appendage), but not deployed/implanted.

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 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: 18161261
• MDR Text Key: 328418602
• Report Number: 2124215-2023-64776
• 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: 11/17/2023

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: 11/02/2023
• Initial Date FDA Received: 11/17/2023
• 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): Required Intervention; Death; Life Threatening; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Race: White