MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. VERSACROSS ACCESS SOLUTION; INTRODUCER, CATHETER

Device Problem Material Integrity Problem (2978)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/03/2022

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 occurred.A left atrial appendage (laa) closure procedure was performed using a watchman truseal access system (was).Intra cardiac echocardiogram (ice) revealed a circumferential pericardial effusion located around the laa pre procedure.The was was advanced and used to dilate the interatrial septum before crossing to the left side of the heart.Transseptal puncture was performed using a versacross access solution kit.The double curve truseal ice catheter was used in an attempt to locate the position of the transeptal puncture radiofrequency (rf) wire and was as neither were visible in their intended locations.The patient became hypotensive and a pericardial tap was performed.Approximately 1600cc of blood was removed from the patient.A blood saturation test determined the blood originated from the left side of the heart.Protamine was administered and the patient underwent monitoring until the pericardial effusion stabilized.The laa closure procedure was aborted to be rescheduled in the future.During physician monitoring, the patient became stable.

• Brand Name: VERSACROSS ACCESS SOLUTION
• Type of Device: INTRODUCER, CATHETER
• 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: 17591981
• MDR Text Key: 321620336
• Report Number: 2124215-2023-44520
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183655
• 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: 08/21/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/21/2023
• 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: 84 YR
• Patient Race: White