MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS LARGE 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 08/30/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced a small pericardial effusion, and the procedure was cancelled due to the inability to perform transseptal puncture.During a left atrial appendage closure (laac) procedure to treat atrial fibrillation, it was noted that the patient had challenging (chicken wing) anatomy.The septum was floppy making for a tough transseptal.After first deployment of a 31mm device, a small pericardial effusion was noted less than 1cm.The patient was stable, and the procedure was continued.Another 31mm device was attempted, and finally another tsp puncture was done and a 27mm device was attempted.The effusion and patient remained stable, however eventually the case was aborted due to the challenging anatomy.No interventions were performed.Transesophageal echocardiography (tte) post procedure showed no change.The patient was admitted to the hospital for monitoring and expected to fully recover.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced a small pericardial effusion, and the procedure was cancelled due to challenging patient anatomy.During a left atrial appendage closure (laac) procedure to treat atrial fibrillation, it was noted that the patient had challenging "chicken wing" anatomy.The septum was floppy making for a tough transseptal.After first deployment of a 31mm device, a small pericardial effusion was noted less than 1cm.The patient was stable, and the procedure was continued.Another 31mm device was attempted, and finally another tsp puncture was done and a 27mm device was attempted.The effusion and patient remained stable, however eventually the case was aborted due to the challenging anatomy.No interventions were performed.Transesophageal echocardiography (tte) post procedure showed no change.The patient was admitted to the hospital for monitoring and expected to fully recover.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: VERSACROSS LARGE 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 ; CA
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17598480
• MDR Text Key: 321684401
• Report Number: 2124215-2023-44085
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201288
• 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: 10/11/2023

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: 07/28/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 10/11/2023
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male