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 Tachycardia (2095); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/24/2022

Event Type  Death  

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 the patient experienced a cardiac perforation and subsequent pericardial effusion and cardiac tamponade.During a left atrial appendage closure (laac) procedure via intracardiac echo (ice) guidance, the non-boston scientific ice catheter and versacross connect were successfully delivered up the inferior vena cava (ivc)/superior vena cava (svc) to the right atrium (ra).The septum visualized with ice, and a safe transseptal (tsp) was performed.At this point, the pigtail wire was advanced in to left atrium (la) and the versacross connect safely made it across the septum.It was then pulled back to the ra with pigtail wire remaining in the la.Ice was advanced along with wire and versacross connect system again delivered into la.At this point, the pigtail wire remained parked in the la while the physician then tried to obtain standard views using the ice catheter.At one point, he informed the ice representative that he could feel resistance and then pectinate ridges were visualized.The ice representative advised he withdraw the ice catheter as it appeared to be inside the appendage.Within a few minutes, fluid started to fill behind the appendage in the transverse sinus, the patient's heart rate became elevated, and a pericardial effusion was identified.The procedure was aborted and a pericardiocentesis was performed by the physician while the operating room (or) prepped to accept the patient for surgical intervention.The patient was also given an auto-transfusion.The patient was taken to surgery, a stitch was placed into the identified hole in the left atrial appendage (laa) and then laa was clipped.The physician thought that the ice catheter had perforated the laa as it clinically aligned with how the patient was presenting.However, the physician also noted that the hole was very small (approximately 18 gauge) and that the hole could have been caused by the versacross wire based on its small size.The patient was stabilized in or and sent to the intensive care unit (icu) for close monitoring.It was noted that a small effusion was present before the procedure began that was assumed to be chronic.(b)(6) 2022 : it was later reported that the patient passed away on (b)(6) 2022.

Manufacturer Narrative

It was further identified that this report is a duplicate of below existing medwatch reports from baylis legacy system.3019751610-2022-00054, 3019751610-2022-00055.

Event Description

It was reported that the patient experienced a cardiac perforation and subsequent pericardial effusion and cardiac tamponade.During a left atrial appendage closure (laac) procedure via intracardiac echo (ice) guidance, the non-boston scientific ice catheter and versacross connect were successfully delivered up the inferior vena cava (ivc)/superior vena cava (svc) to the right atrium (ra).The septum visualized with ice, and a safe transseptal (tsp) was performed.At this point, the pigtail wire was advanced in to left atrium (la) and the versacross connect safely made it across the septum.It was then pulled back to the ra with pigtail wire remaining in the la.Ice was advanced along with wire and versacross connect system again delivered into la.At this point, the pigtail wire remained parked in the la while the physician then tried to obtain standard views using the ice catheter.At one point, he informed the ice representative that he could feel resistance and then pectinate ridges were visualized.The ice representative advised he withdraw the ice catheter as it appeared to be inside the appendage.Within a few minutes, fluid started to fill behind the appendage in the transverse sinus, the patients heart rate became elevated, and a pericardial effusion was identified.The procedure was aborted and a pericardiocentesis was performed by the physician while the operating room (or) prepped to accept the patient for surgical intervention.The patient was also given an auto-transfusion.The patient was taken to surgery, a stitch was placed into the identified hole in the left atrial appendage (laa) and then laa was clipped.The physician thought that the ice catheter had perforated the laa as it clinically aligned with how the patient was presenting.However, the physician also noted that the hole was very small (approximately 18 gauge) and that the hole could have been caused by the versacross wire based on its small size.The patient was stabilized in or and sent to the intensive care unit (icu) for close monitoring.It was noted that a small effusion was present before the procedure began that was assumed to be chronic.24oct2022: it was later reported that the patient passed away on (b)(6) 2022.It was further identified that this report is a duplicate of below existing medwatch reports from baylis legacy system.3019751610-2022-00054, 3019751610-2022-00055.

• 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: 17585802
• MDR Text Key: 321557041
• Report Number: 2124215-2023-44065
• 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,Followup
• Report Date: 10/25/2023

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: 10/24/2022
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male