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

Model Number NR7TCSIY

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

Patient Problem Cardiac Tamponade (2226)

Event Date 04/20/2022

Event Type  Death  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a male patient born (b)(6) ((b)(6)) underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a navistar® rmt thermocool® electrophysiology catheter.The patient suffered cardiac tamponade requiring surgical intervention and the patient died.During an afib procedure a cardiac tamponade was diagnosed via intracardiac echo (ice) catheter after the patient's pressure dropped.A pericardiocentesis was performed by the physician.The patient was stable at the time of the call.The patient has a dual chamber pacemaker and has had two previous ablations, one for cti and one for rvot pvc.The patient had to go to open heart surgery to repair the perforation but is now recovering in stable condition.It's suspected the perforation occurred near the left atrial appendage while burning.On follow up the physicians' new theory is that she perforated with the pentaray while mapping.The outcome of the adverse event was the patient died.The patient required extended hospitalization because of the adverse event, the patient was hospitalized until they passed away.A transseptal puncture was performed.There was no evidence of steam pop.The correct catheter settings were selected on the generator.There were no significant errors displayed during the event.The generator used in the case was a smartablate.The sheath used was a small curl agilis.According to the bwi company representative all of this information is straight from the death certificate: the date of death is (b)(6) 2022 at 15:10.The cause of death according to death certificate is: 1.Acute on chronic liver failure/ hyperlipidemia 2.Sepsis 3.Cardiac tamponade 4.Ventricular tachycardia/ atrial fibrillation and manner of death is listed as natural.It was certified by the doctor on (b)(6) 2022.While the perforation wasn't listed as cause of death, the physician has verbally stated she believed the pentaray or the sheath caused the perforation that was then repaired surgically.The physician believes rmt to be too soft of a catheter to perforate.Perforation was found near anterior base of left atrial appendage and repaired with a 5mm patch.The pentaray is not available for return, it was not kept because the rmt thermocool was the catheter the physician suspected to be responsible.Bwi devices will be conservatively reported as ablation took place, therefore ablation catheter cannot be excluded as potential cause even though the physician acknowledged that it could have been either the pentaray or the rmt thermocool.This report is for the navistar rmt.The report for the pentaray was submitted in manufacturer report number 2029046-2022-01052.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

The device evaluation was completed on 10-jun-2022.It was reported that a male patient born (b)(6)1949 (242pounds) underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a navistar® rmt thermocool® electrophysiology catheter.The patient suffered cardiac tamponade requiring surgical intervention and the patient died.During an afib procedure a cardiac tamponade was diagnosed via intracardiac echo (ice) catheter after the patient's pressure dropped.A pericardiocentesis was performed by the physician.The patient was stable at the time of the call.The patient has a dual chamber pacemaker and has had two previous ablations, one for cti and one for rvot pvc.The patient had to go to open heart surgery to repair the perforation but is now recovering in stable condition.It's suspected the perforation occurred near the left atrial appendage while burning.On follow up the physicians' new theory is that she perforated with the pentaray while mapping.The outcome of the adverse event was the patient died.The patient required extended hospitalization because of the adverse event, the patient was hospitalized until they passed away.Device evaluation details: a picture was provided showing a screenshot of the smartablate display settings.The photo did not provide sufficient information related to the reported event and therefore no result can be obtained from it.The product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the navistar® rmt thermocool® electrophysiology catheter.Per the event, several tests were performed.The magnetic sensor functionality was tested on carto and the device was recognized and failed visualization.No error was observed.The device was dissected on the tip area, loss of electrical continuity at the sensor was found, and it was determined that the root cause was an internal failure of the sensor.In addition, the product was irrigating correctly.No other malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device number 30659106m, and no internal actions related to the complaint were found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event.Investigation findings: open circuit (c0205)/ investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the loss of electrical continuity at the sensor.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 10-jun-2022, it was noted that the product return status, where the product was received on 04-may-2022, was not included in the initial 3500a report.Therefore, the d9.Device available for evaluation, d 9.Date device returned to manufacturer, and d9.Device available for evaluation were updated on this report.

• 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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14436266
• MDR Text Key: 292031184
• Report Number: 2029046-2022-01053
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

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
• Device Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30659106M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 06/10/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AGILIS SHEATH; CARTO 3 SYSTEM; SMARTABLATE GENERATOR; UNSPECIFIED TRANSSEPTAL NEEDLE
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention; Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 110 KG