MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Device Problems Leak/Splash (1354); Output Problem (3005)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Diminished Pulse Pressure (2606); Pericardial Effusion (3271); Asystole (4442)

Event Date 05/30/2023

Event Type  Injury  

Event Description

"the patient was noted to have hypotension therefore intracardiac echo was constantly monitoring and had a minimal pericardial effusion at the beginning of the procedure but pericardial fusion was increased after ablation.Patient subsequently arrested on the table with loss of pressure and went asystolic/pea (pulseless electrical activity).The patient required cpr (cardiopulmonary resuscitation) during the procedure and medications (dopamine and epinephrine) were given stabilize blood pressures and eventually a heart rate.Cardiovascular surgeon was consulted and arrived at bedside.The bleeding from the pericardial tissue has been reduced but was still actively draining into the drainage bag.Patients anticoagulation was reversed with protamine sulfate as well as the prothrombin concentrate from a previously taken xarelto on (b)(6) 2023 (stated in timeout).Patient was stabilized and transferred to io icu (intensive care unit)." "last night i had the opportunity to scrub with cardiovascular surgeon during the surgery the patient had perforation at the site of mitral isthmus ablation and [cardiovascular surgeon] repaired it is notable that during the ablation of the mitral isthmus line there was an error sign in the carto 3 system excessive current leak and we had to stop ablation and disconnect the ablation catheter and reconnect to the system." reference report: mw5118185.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, INC.
• MDR Report Key: 17077781
• MDR Text Key: 316756114
• Report Number: MW5118186
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• 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
• Patient Sequence Number: 1
• Treatment: THERMOCOOL SMARTTOUCH SF ABLATION CATHETER, INTRACARDIAC ECHO, DOPAMINE, EPINEPHRINE, PROTAMINE SULFATE, XARELTO.
• Patient Outcome(s): Life Threatening; Disability; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White