MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number NR7TCSIY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Thrombosis (2100); Cardiac Tamponade (2226); No Code Available (3191)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent a ventricular tachycardia (vt) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered a cardiac tamponade (requiring pericardiocentesis), cardiac arrest (requiring cardiopulmonary resuscitation), and thrombosis (requiring surgical intervention).During mapping phase, the patient became hypotensive and a pericardial effusion was confirmed via intracardiac echocardiography (ice).Pericardiocentesis yielded 600 ml.Patient became hypotensive a 2nd time.Cardiopulmonary resuscitation (cpr) was administered.At an unspecified point, a thrombus was detected via ice.Patient was transported to the operating room for a surgical intervention.Patient required extended hospitalization as a result of the adverse event.Patient fully recovered.Medical history includes ischemic cardiomyopathy, hypertension, diabetes, and coronary artery disease.There were no patient factors cited that may have contributed to the adverse event.Physician¿s opinion regarding the cause of the tamponade is that it may have resulted from the stiff portion of the navistar rmt catheter perforating the left ventricular apex.Physician indicated that since the sheath was positioned at the mitral valve, and the catheter was not retracted into the sheath, the sheath would not have been able to perforate the left ventricular apex.There were no issues, errors, or malfunctions reported on any bwi products or equipment during the procedure.Transseptal puncture was performed with an unspecified transseptal needle.There is no sheath information.There is no information regarding generator parameters, generator settings, power titration, overall ablation time at the site of injury, or last ablation cycle time at the site of injury, as no ablation was performed.There is no information regarding irrigated catheter flow setting.Patient received anticoagulant during the procedure with activated clotting time (act) maintained at approximately 350 seconds.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (b)(4) 2018.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer ref no: (b)(4).

Manufacturer Narrative

Device evaluation summary: upon receipt, the device was visually inspected and was found in good condition.There were kinks observed on the catheter shaft approximately 27 and 28cm from the distal tip.The magnetic sensor was tested in conjunction with a carto 3 system.And the catheter was properly visualized with no error messages.An electrical test was performed, and the catheter was found within specifications.No electrical malfunctions were observed.Additionally, the catheter was tested with a radiofrequency generator.Temperature and impedance values were observed within specifications.Irrigation and deflection tests were performed, which the catheter passed.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use state that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer¿s reference number: (b)(4).

• Brand Name: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7639467
• MDR Text Key: 112413684
• Report Number: 2029046-2018-01737
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2021
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30012546M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 07/31/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 90