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

Lot Number VMFD040923

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/13/2023

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 pericardial effusion, tamponade, perforation has occurred.During a watchman procedure, a versacross connect kit was selected for use.The versacross radio frequency wire was being advanced into the superior vena cava (svc) however there was a difficulty noted to follow up to the svc.Some manipulations with versacross and watchman sheath was performed for about a minute or two to track wire to the svc and eventually found its path to the correct location.Transseptal was achieved without any issues and the watchman device was implanted.A small effusion was noted during our post procedural check.Effusion was observed for about fifteen minutes and was compared with pre-check transesophageal echocardiogram (tee) imaging of the effusion.It was difficult to determine if the effusion was present at baseline because of the grainy-ness of our pre-imaging.After waiting fifteen minutes, the effusion was unchanged and vital signs were stable.Patient was sent to recovery and upon waking began to complain of chest pains and pressures were noted to be slightly hypotensive.A transthoracic echocardiogram (tte) was ordered and effusion was notably larger than in the cath lab.A pericardiocentesis was performed and compression were given multiple times while pulling fluid off the pericardial space.The effusion was resolving upon draw back, but would continue to appear after a few moments.The patient would regain a pulse on and off during this time and cardiopulmonary resuscitation (cpr) was administered appropriately.Computed tomography (ct) surgery was requested and determined an open heart was necessary to stop the effusion.Upon further inspection during open heart the surgeon noted that a small perforation was found in the anterior aspect of the right atrium, approximately a 'wire sized' hole.The patient was sent to intensive care unit intubated and stable.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: 18365414
• MDR Text Key: 331004973
• Report Number: 2124215-2023-72164
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00685447012580
• UDI-Public: 00685447012580
• 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: 12/20/2023

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
• Device Lot Number: VMFD040923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female