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 Perforation (2001); Pericardial Effusion (3271)

Event Date 08/29/2023

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 (pe) happened during a watchman procedure.A versacross connect was selected for use during a left atrium appendage closure to treat atrial fibrillation (a fib).The versacross rf pigtail wire was advanced to superior vena cava (svc).A 3000 units of heparin had been administered to patient prior to transeptal puncture.The physician began the transseptal (tsp) drop down from svc, when it was noticed that the versacross rf wire was getting tangled with atrial lead during drop down.However, the physician was able to untangle catheter from lead and the lead repositioned abruptly on fluoro.Then, it was noted that based on the tenting, the position was inferior and posterior on the septum, and a radio frequency was applied.When advancing versacross rf wire, it could not be observed in left atrium on transesophageal echocardiography (tee).Hence, the versacross rf wire was pulled back into dilator and tee scanned for effusion, which was not observed.The physician believed that tenting on septum did not change and continued with transseptal puncture, and administered remaining heparin dose to the patient.After successful transseptal crossing, tee operator observed a perforation followed by pericardial effusion.Nonetheless, the physician continued with device deployment and a 31mm device was successfully deployed, and since it passed criteria, device was released.Thus, after re-assessing tee views, a pericardial tap was performed, and effusion appeared to be resolving based on tee.The physician also noted some resistance pulling back on syringe while draining blood.Assessing tee again, it was determined that effusion was getting better, and that the pe was a right sided effusion due to initial tsp crossing or interaction of tsp catheter with atrial lead.Surgeon reevaluated tee and determined that the patient needed volume and pacing device settings needed to be adjusted.The procedure was completed.There is no reason to believe that the versacross wire malfunctioned during the procedure.It is expected that the patient fully recovers.The patient was not admitted to hospital beyond standard of care, but stayed overnight.The current status for the patient is unknown.The patient has atrial leads that were unclear tee imaging.No pe was noted prior to the procedure.The patient had stopped eliquis in july/2023.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: 17817911
• MDR Text Key: 324263525
• Report Number: 2124215-2023-49615
• 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: 09/26/2023

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: 08/29/2023
• Initial Date FDA Received: 09/26/2023
• 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; Other
• Patient Age: 80 YR
• Patient Sex: Female