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

Device Problem Positioning Problem (3009)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 02/19/2024

Event Type  Injury  

Event Description

It has been reported that a versacross connect laac access solution kit was selected for use for a watchman left atrial appendage closure (laac) procedure.A pericardial effusion (pe) occurred and the procedure was cancelled.During the procedure, the physician mentioned they had some difficulty with the transseptal crossing, which may have been when the effusion occurred.Post-implant, the physician noted staining through fluoroscopy and checked for an effusion using transesophageal echocardiogram (tee).A pericardial effusion (pe) was then found with a 20 pt drop on the patients systolic blood pressure.Initially, dopamine was given and the pressure was held to sustain the hypotension.Next, the physician removed everything out of the left atrium and provided protamine to manage the effusion.During this time, the device began to embolize and the patients blood pressure was holding steady.The watchman flx closure device eventually floated through the valves and settled in the aortic arch.An 18fr 40mm sheath was then placed in the left frontoanterior position (lfa).The physician first tried to use non-boston scientific device - ensnare, which brought the device down to the descending aorta.Next, it was switched to a non-boston scientific device - raptor, and were able to successfully retrieve the watchman device.The patient has been admitted to stepdown overnight, and it was discharge later on (patient is expected to fully recover).The device is not expected to be returned for analysis (discarded).Prior to the procedure, no effusion was seen.The patient was on warfarin when the issue occurred.Activated clotting time (act) at this time was 240 after the protamine was given.It was further noted that that a versacross connect system was initially used but the physician was having difficulty crossing the septum.Multiple attempts were required to track up and down on the septum.They then switched to an sro (non-boston scientific) catheter and used the original first versacross rf wire with it.The rf wire was then able to cross the septum successfully without the application of rf energy, either through direct pressure or a patent foramen ovale (pfo), and tenting was confirmed for a brief period at this time.In addition, they stated that the septum appeared to be off axis, making it difficult to access or even have the transseptal sheath touch the septum.The right atrium also did not appear to be dilated which could have been a possible cause of the effusion.The physician also tried to manipulate the curve on the versacross connect but was still unable to reach the septum until switching to the new sheath due to the patient's anatomy.No other issue was noted.In the physician's opinion, a difficulty transeptal may have contributed to the effusion.The blood pressure dropped from 100 systolic to 80 systolic.There was no reason to believe that the versacross rf wire or dilator did not malfunction during the procedure.The issue was due to challenging patient anatomy and the issue was resolved by using a different tool to achieve transseptal.The physician also stated that the versacross dilator did not contribute to the adverse event noted, they believe it was a result of the transseptal process.In addition, the versacross devices also did not play a role in the embolism noted, they stated that it occurred due to the premature release of the device by the physician, and that they should have waited until the pass evaluation was completed before doing so.

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: 18926819
• MDR Text Key: 337945779
• Report Number: 2124215-2024-16045
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• 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
• Date Manufacturer Received: 02/19/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White