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 Problem Pericardial Effusion (3271)

Event Date 08/24/2023

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 pericardial effusion (pe) occurred.It was reported that a versacross connect access solution was selected for use during a left atrial appendage (laa) closure.The transseptal puncture (tsp) was performed with no issues reported.The watchman access system was positioned and watchman closure device and delivery system (wds) was advanced, deployed and released in the intended location.After release of the wds, a pericardial effusion (pe) was observed surrounding the left atrium/posterior wall.Thus, a pericardiocentesis was performed (drained off 280 cc of fluid from the pericardium& 230cc were given back to the patient via cell saver) and the patient is fully recovered.It was suspected that the pe started prior to or during tsp.It was noted a small trace effusion prior to procedure - trace (< 10mm) and presumed cause is not known).After the procedure, the pe grew to moderate (>10mm).The pe grew slowly during the procedure.It was thought from the transeptal puncture but it was not noticed until after watchman implantation.The physician crossed through (without use of rf) a pfo/asd with versacross connect.It is estimated that the perforation has happened at the tsp into la (possibly posterior wall); perforation did not occur in laa since no contrast staining into the pericardial sac took place during injections.The patient anatomy was aneurysmal septum with asd/pfo present.The imaging/visualizing the wire was seen easily in short access at transeptal but difficulties in the bicaval view.The rf wire did not tent, as the sheath went through the already present pfo/asd (thus, no rf was applied).The pericardial effusion was located circumferential.The pe was noticed during watchman deployment, chose to release, reverse with protamine (150cc), then watch if it grew.There is no reason to believe that the versacross wire malfunctioned during the procedure (was not used).The patient have a prior history of tsp.The act therapeutic during the procedure was 290.Multiple track downs were needed due to the lost sight of transeptal access system (fell too low).It was rewired up to superior vena cava (svc) 2 times prior to crossing the pfo at the septum.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: 17777278
• MDR Text Key: 323768745
• Report Number: 2124215-2023-49279
• 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: 09/19/2023

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: 08/24/2023
• Initial Date FDA Received: 09/19/2023
• 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): Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White